Trial Outcomes & Findings for OsteoCool Tumor Ablation Post-Market Study (NCT NCT03249584)
NCT ID: NCT03249584
Last Updated: 2021-10-01
Results Overview
Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
COMPLETED
NA
218 participants
From Baseline to 3 months post RF ablation
2021-10-01
Participant Flow
At the time of the primary objective assessment (Apr 2019), 106 subjects were enrolled. Enrollment ended Feb 2020 with 218 total subjects which allowed for assessment of secondary objective and long-term effectiveness and safety.
12 of 218 subjects exited prior to RF Ablation (RFA) due to failing in/exclusion criteria, withdrawal of consent, etc. 206 total subjects underwent a single OsteoCool™ RFA procedure. For effectiveness, subjects were separated into 2 study Groups (Thoracic/Lumbar and Periacetabulum/Iliac Crest/Sacrum) based on the location of each subject's ablation(s); subjects were combined for safety.
Participant milestones
| Measure |
OsteoCool™ RF Ablation in Thoracic/Lumbar Spine
Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.
|
OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum
Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
184
|
22
|
|
Overall Study
Month 3
|
132
|
15
|
|
Overall Study
Month 3 Primary/Secondary Objectives
|
42
|
15
|
|
Overall Study
Month 6
|
101
|
13
|
|
Overall Study
COMPLETED
|
51
|
8
|
|
Overall Study
NOT COMPLETED
|
133
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OsteoCool™ RF Ablation in Thoracic/Lumbar Spine
n=184 Participants
Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.
|
OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum
n=22 Participants
Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 13.4 • n=184 Participants
|
65.3 years
STANDARD_DEVIATION 9.4 • n=22 Participants
|
63.7 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=184 Participants
|
8 Participants
n=22 Participants
|
113 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=184 Participants
|
14 Participants
n=22 Participants
|
93 Participants
n=206 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
150 participants
n=184 Participants
|
18 participants
n=22 Participants
|
168 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
27 participants
n=184 Participants
|
4 participants
n=22 Participants
|
31 participants
n=206 Participants
|
|
Region of Enrollment
France
|
6 participants
n=184 Participants
|
0 participants
n=22 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=184 Participants
|
0 participants
n=22 Participants
|
1 participants
n=206 Participants
|
|
Wost Pain Score
|
7.8 units on a scale
STANDARD_DEVIATION 1.7 • n=184 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 1.4 • n=22 Participants
|
7.8 units on a scale
STANDARD_DEVIATION 1.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 3 months post RF ablationDemonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
Outcome measures
| Measure |
OsteoCool™ RF Ablation in Thoracic/Lumbar Spine
n=42 Participants
Subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies).
|
|---|---|
|
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
|
-4.1 units on a scale
Interval -5.2 to -3.1
|
SECONDARY outcome
Timeframe: From Baseline to 3 months post RF ablationCharacterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain. The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.
Outcome measures
| Measure |
OsteoCool™ RF Ablation in Thoracic/Lumbar Spine
n=15 Participants
Subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies).
|
|---|---|
|
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
|
-4.5 units on a scale
Interval -6.1 to -2.8
|
Adverse Events
Total OsteoCool™ RF Ablation
Serious adverse events
| Measure |
Total OsteoCool™ RF Ablation
n=206 participants at risk
Subjects underwent a single OsteoCool™ RF Ablation procedure.
OsteoCool™ RF Ablation: The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.49%
1/206 • Number of events 1 • From RF Ablation to Month 12.
AE data are based on all available safety data (ie, based on 206 total subjects undergoing RF Ablation including 184 in only the thoracic and/or lumbar vertebral body(ies) and 22 in the periacetabulum, iliac crest, and/or sacrum). Device, therapy, and procedure related AEs were considered reportable. Deaths due to underlying malignancy were not considered AE; all deaths were reviewed for causality by a Clinical Events Committee.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
1/206 • Number of events 1 • From RF Ablation to Month 12.
AE data are based on all available safety data (ie, based on 206 total subjects undergoing RF Ablation including 184 in only the thoracic and/or lumbar vertebral body(ies) and 22 in the periacetabulum, iliac crest, and/or sacrum). Device, therapy, and procedure related AEs were considered reportable. Deaths due to underlying malignancy were not considered AE; all deaths were reviewed for causality by a Clinical Events Committee.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.49%
1/206 • Number of events 1 • From RF Ablation to Month 12.
AE data are based on all available safety data (ie, based on 206 total subjects undergoing RF Ablation including 184 in only the thoracic and/or lumbar vertebral body(ies) and 22 in the periacetabulum, iliac crest, and/or sacrum). Device, therapy, and procedure related AEs were considered reportable. Deaths due to underlying malignancy were not considered AE; all deaths were reviewed for causality by a Clinical Events Committee.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Participating Institutions may publish the results provided that any such Publication shall be after the multi-center publication is released or presented and shall be provided to Medtronic for review at least 30 days prior to submission or presentation.
- Publication restrictions are in place
Restriction type: OTHER