Trial Outcomes & Findings for Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation (NCT NCT06071715)
NCT ID: NCT06071715
Last Updated: 2026-04-08
Results Overview
The "average" pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. The primary outcome will be the change from baseline in average pain intensity as measured with the numeric rating scale 1 month following the initial intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline and Month 1
Results posted on
2026-04-08
Participant Flow
Participant milestones
| Measure |
Cryoneurolysis Only Treatment
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Comparator Only
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Comparator First, Then Active Cryoneurolysis Treatment
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Active crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
4
|
|
Overall Study
COMPLETED
|
7
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cryoneurolysis Only
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Comparator Only
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Comparator First, Then Optional Cryoneurolysis Treatment
n=4 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Active crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10 • n=7 Participants
|
47 years
STANDARD_DEVIATION 0 • n=1 Participants
|
62 years
STANDARD_DEVIATION 19 • n=4 Participants
|
60 years
STANDARD_DEVIATION 14 • n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
1 participants
n=1 Participants
|
4 participants
n=4 Participants
|
12 participants
n=12 Participants
|
|
Weight
|
82 kg
STANDARD_DEVIATION 16 • n=7 Participants
|
77 kg
STANDARD_DEVIATION 0 • n=1 Participants
|
114 kg
STANDARD_DEVIATION 31 • n=4 Participants
|
93 kg
STANDARD_DEVIATION 26 • n=12 Participants
|
|
Height
|
176 cm
STANDARD_DEVIATION 12 • n=7 Participants
|
180 cm
STANDARD_DEVIATION 0 • n=1 Participants
|
182 cm
STANDARD_DEVIATION 9 • n=4 Participants
|
178 cm
STANDARD_DEVIATION 10 • n=12 Participants
|
|
Body mass index
|
26.4 kg/m^2
STANDARD_DEVIATION 4.0 • n=7 Participants
|
29 kg/m^2
STANDARD_DEVIATION 0 • n=1 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 8.6 • n=4 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6 • n=12 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 1The "average" pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. The primary outcome will be the change from baseline in average pain intensity as measured with the numeric rating scale 1 month following the initial intervention.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Average Pain Intensity Change From Baseline 1 Month Post-intervention
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: Data was collected at all time points for all groups.
The "average" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Average Daily Phantom Pain Intensity Change From Baseline
Day 1
|
-3 score on a scale
Interval -5.0 to -1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -1.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Day 7
|
-1 score on a scale
Interval -1.5 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -1.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval -0.5 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Month 2
|
-1 score on a scale
Interval -2.0 to 0.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval -0.5 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Month 4
|
-1 score on a scale
Interval -1.0 to 0.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Phantom Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "worst" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Day 1
|
-3 score on a scale
Interval -5.5 to 0.5
|
0 score on a scale
Interval 0.0 to 0.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval -2.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval -1.0 to 0.5
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Month 4
|
1 score on a scale
Interval -1.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Phantom Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "least" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Least Daily Phantom Pain Intensity Change From Baseline
Day 1
|
-2 score on a scale
Interval -2.0 to -1.0
|
-2 score on a scale
Interval -2.0 to -2.0
|
-2 score on a scale
Interval -2.0 to -1.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval -2.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -2.0 to 1.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval -2.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Month 2
|
-1 score on a scale
Interval -2.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Month 3
|
-1 score on a scale
Interval -2.0 to 0.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval -2.0 to 1.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Phantom Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "current" phantom pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Current Daily Phantom Pain Intensity Change From Baseline
Day 1
|
-2 score on a scale
Interval -2.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Day 7
|
-1 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Month 1
|
1 score on a scale
Interval -2.0 to 1.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval -3.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval -1.0 to 1.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Month 4
|
00 score on a scale
Interval -1.0 to 0.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Daily Phantom Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "average" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Day 1
|
3 score on a scale
Interval 0.0 to 3.0
|
—
|
—
|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Average Daily Phantom Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "worst" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 0.0 to 3.0
|
—
|
—
|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Worst Phantom Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "least" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Day 1
|
3 score on a scale
Interval 0.0 to 3.0
|
—
|
—
|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Phantom Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "current" phantom pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 0.0 to 4.0
|
—
|
—
|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Phantom Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "average" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Day 7
|
2 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 0.0 to 4.0
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 1.5
|
1 score on a scale
Interval 1.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.5
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 1.0 to 1.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Average Daily Residual Limb Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "worst" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Day 1
|
6 score on a scale
Interval 2.0 to 8.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Day 7
|
4 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 5.5
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 0.0
|
7 score on a scale
Interval 0.0 to 8.0
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 0.0
|
2.5 score on a scale
Interval 0.0 to 3.0
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 4.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 4.0
|
|
Worst Daily Residual Limb Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "least" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Day 1
|
0 score on a scale
Interval 0.0 to 2.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Least Daily Residual Limb Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The "current" residual limb pain level measured using the numeric rating scale at the time of the data collection call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Current Residual Limb Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 1.0 to 5.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Day 7
|
1 score on a scale
Interval 0.0 to 3.5
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Current Residual Limb Pain Intensity Change From Baseline
Month 12
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "average" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 0.0 to 5.5
|
—
|
—
|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Day 7
|
2 score on a scale
Interval 0.0 to 4.0
|
—
|
—
|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 4.0
|
—
|
—
|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 1.5
|
—
|
—
|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 1.0
|
—
|
—
|
|
CROSSOVER Average Daily Residual Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "worst" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Day 1
|
6 score on a scale
Interval 0.0 to 8.0
|
—
|
—
|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Day 7
|
4 score on a scale
Interval 0.0 to 6.0
|
—
|
—
|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 5.5
|
—
|
—
|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 4.0
|
—
|
—
|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 2.0
|
—
|
—
|
|
CROSSOVER Worst Daily Residual Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 4.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "least" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Day 1
|
0 score on a scale
Interval 0.0 to 2.0
|
—
|
—
|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Day 7
|
0 score on a scale
Interval 0.0 to 2.5
|
—
|
—
|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 1.0
|
—
|
—
|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Least Daily Residual Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The "current" residual limb pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Day 1
|
2 score on a scale
Interval 1.0 to 5.0
|
—
|
—
|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Day 7
|
1 score on a scale
Interval 0.0 to 4.0
|
—
|
—
|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Month 1
|
0 score on a scale
Interval 0.0 to 2.0
|
—
|
—
|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Month 2
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Month 3
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
CROSSOVER Current Residual Pain Intensity Change From Baseline
Month 4
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12This measure is a 7-point ordinal scale requiring the subject to rate the current severity of their global situation as it relates to phantom limb pain (as defined by each individual) compared to their baseline. This scale has the words "very much worse" to the left by the number one, and "very much improved" to the right, adjacent to the number seven. The words "no change" are in the middle of the scale above the number four.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Patient Global Impression of Change, Initial Intervention
Day 1
|
7 score on a scale
Interval 4.5 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change, Initial Intervention
Day 7
|
4 score on a scale
Interval 4.0 to 5.5
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change, Initial Intervention
Month 1
|
4 score on a scale
Interval 4.0 to 4.5
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Patient Global Impression of Change, Initial Intervention
Month 2
|
4 score on a scale
Interval 4.0 to 5.5
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change, Initial Intervention
Month 3
|
4 score on a scale
Interval 4.0 to 4.5
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change, Initial Intervention
Month 4
|
4 score on a scale
Interval 4.0 to 4.5
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Patient Global Impression of Change, Initial Intervention
Month 12
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4This measure is a 7-point ordinal scale requiring the subject to rate the current severity of their global situation as it relates to phantom limb pain (as defined by each individual) compared to their baseline. This scale has the words "very much worse" to the left by the number one, and "very much improved" to the right, adjacent to the number seven. The words "no change" are in the middle of the scale above the number four. For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
CROSSOVER Patient Global Impression of Change
Day 1
|
7 score on a scale
Interval 4.5 to 7.0
|
—
|
—
|
|
CROSSOVER Patient Global Impression of Change
Day 7
|
4 score on a scale
Interval 4.0 to 5.5
|
—
|
—
|
|
CROSSOVER Patient Global Impression of Change
Month 1
|
4 score on a scale
Interval 4.0 to 4.0
|
—
|
—
|
|
CROSSOVER Patient Global Impression of Change
Month 2
|
4 score on a scale
Interval 4.0 to 5.0
|
—
|
—
|
|
CROSSOVER Patient Global Impression of Change
Month 3
|
4 score on a scale
Interval 4.0 to 4.5
|
—
|
—
|
|
CROSSOVER Patient Global Impression of Change
Month 4
|
4 score on a scale
Interval 4.0 to 4.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The Brief Pain Inventory's interference sub-scale includes 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The minimum value of 0 (better with no interference) and maximum value of 70 (worse with maximum interference).
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=7 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
n=1 Participants
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
n=4 Participants
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
|---|---|---|---|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Day 1
|
15 score on a scale
Interval 3.0 to 26.0
|
45 score on a scale
Interval 45.0 to 45.0
|
45 score on a scale
Interval 42.0 to 51.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Day 7
|
20 score on a scale
Interval 13.0 to 47.0
|
45 score on a scale
Interval 45.0 to 45.0
|
45 score on a scale
Interval 42.0 to 53.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Month 1
|
38 score on a scale
Interval 27.0 to 50.0
|
40 score on a scale
Interval 40.0 to 40.0
|
40 score on a scale
Interval 37.0 to 42.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Month 2
|
31 score on a scale
Interval 20.0 to 40.0
|
46 score on a scale
Interval 46.0 to 46.0
|
46 score on a scale
Interval 41.0 to 50.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Month 3
|
30 score on a scale
Interval 20.0 to 40.0
|
40 score on a scale
Interval 40.0 to 40.0
|
40 score on a scale
Interval 40.0 to 45.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Month 4
|
30 score on a scale
Interval 20.0 to 50.0
|
42 score on a scale
Interval 42.0 to 42.0
|
42 score on a scale
Interval 20.0 to 47.0
|
|
Brief Pain Inventory (Interference Sub Scale), Initial Intervention
Month 12
|
0 score on a scale
Interval 0.0 to 7.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The Brief Pain Inventory's interference sub-scale includes 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference;10=complete interference\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The minimum value of 0 (better with no interference) and maximum value of 70 (worse with maximum interference). For this outcome, data is for the time period after the CROSSOVER treatment.
Outcome measures
| Measure |
Cryoneurolysis Only (no Sham Crossover)
n=4 Participants
Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
|
Sham Only (no Active Crossover)
Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
|
Sham Initial Treatment Followed by Active Crossover
Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.
Crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Day 1
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12 score on a scale
Interval 3.0 to 25.0
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Day 7
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20 score on a scale
Interval 18.0 to 45.0
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—
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Month 1
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40 score on a scale
Interval 30.0 to 50.0
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—
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Month 2
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32 score on a scale
Interval 20.0 to 40.0
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—
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Month 3
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30 score on a scale
Interval 20.0 to 40.0
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CROSSOVER Brief Pain Inventory (Interference Sub Scale)
Month 4
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30 score on a scale
Interval 20.0 to 50.0
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—
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SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of phantom limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of each phantom limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of residual limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of each residual limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of non-painful phantom sensations experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of non-painful phantom sensations experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of phantom limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of residual limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of each phantom limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of each residual limb pain experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Number of occurrences of non-painful sensations experienced in the previous 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4Population: We inadvertently left this variable off the case report forms, so not information was collected.
Average duration of non-painful sensations experienced in the previous 24 hours
Outcome measures
Outcome data not reported
Adverse Events
Cryoneurolysis Only (no Sham Crossover)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Only (no Active Crossover)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Initial Treatment Followed by Active Crossover
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place