Trial Outcomes & Findings for A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control (NCT NCT04796935)
NCT ID: NCT04796935
Last Updated: 2024-06-11
Results Overview
Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
End of procedure, 1 per participant
Results posted on
2024-06-11
Participant Flow
After enrollment, subjects meeting eligibility criteria were randomized; the rest were considered screen failures.
Participant milestones
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
48
|
|
Overall Study
Received Randomized Location Method
|
30
|
46
|
|
Overall Study
Achieved Procedure Success
|
30
|
41
|
|
Overall Study
COMPLETED
|
40
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Device not available
|
1
|
0
|
|
Overall Study
Trained provider not available
|
1
|
0
|
Baseline Characteristics
Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
Baseline characteristics by cohort
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
ITT
|
43.8 years
STANDARD_DEVIATION 17.67 • n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
40.5 years
STANDARD_DEVIATION 18.47 • n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
42.0 years
STANDARD_DEVIATION 18.07 • n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Continuous
PP
|
41.4 years
STANDARD_DEVIATION 15.55 • n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
39.3 years
STANDARD_DEVIATION 17.78 • n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
40.1 years
STANDARD_DEVIATION 16.8 • n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
ITT · Adolescent (<22)
|
2 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
3 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
5 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
ITT · Young Adult (22-40)
|
19 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
28 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
47 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
ITT · Middle-aged Adult (41-65)
|
15 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
10 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
25 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
ITT · Older Adult (>65)
|
6 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
7 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
13 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
PP · Adolescent (<22)
|
1 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
3 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
4 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
PP · Young Adult (22-40)
|
12 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
25 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
37 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
PP · Middle-aged Adult (41-65)
|
10 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
8 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Age, Customized
PP · Older Adult (>65)
|
2 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
5 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
7 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Sex: Female, Male
ITT · Female
|
29 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
36 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
65 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Sex: Female, Male
ITT · Male
|
13 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
12 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
25 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Sex: Female, Male
PP · Female
|
21 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
32 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
53 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Sex: Female, Male
PP · Male
|
4 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
9 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
13 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
ITT · Hispanic or Latino
|
9 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
14 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
23 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
ITT · Not Hispanic or Latino
|
33 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
33 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
66 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
ITT · Unknown or Not Reported
|
0 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
PP · Hispanic or Latino
|
6 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
12 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
PP · Not Hispanic or Latino
|
19 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
28 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
47 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Ethnicity (NIH/OMB)
PP · Unknown or Not Reported
|
0 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · American Indian or Alaska Native
|
0 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · Asian
|
2 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
3 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
2 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · Black or African American
|
8 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
10 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · White
|
27 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
32 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
59 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · More than one race
|
0 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
ITT · Unknown or Not Reported
|
4 Participants
n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
4 Participants
n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
8 Participants
n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · American Indian or Alaska Native
|
0 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · Asian
|
1 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
2 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
2 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · Black or African American
|
6 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
7 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
13 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · White
|
16 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
29 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
45 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · More than one race
|
0 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
0 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Race (NIH/OMB)
PP · Unknown or Not Reported
|
1 Participants
n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
3 Participants
n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
4 Participants
n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Height
ITT
|
165.7 cm
STANDARD_DEVIATION 9.53 • n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
165.3 cm
STANDARD_DEVIATION 10.36 • n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
165.5 cm
STANDARD_DEVIATION 9.93 • n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Height
PP
|
163.5 cm
STANDARD_DEVIATION 8.74 • n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
164.8 cm
STANDARD_DEVIATION 10.45 • n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
164.3 cm
STANDARD_DEVIATION 9.79 • n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Weight
ITT
|
81.6 kg
STANDARD_DEVIATION 19.40 • n=42 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
80.6 kg
STANDARD_DEVIATION 17.71 • n=48 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
81.0 kg
STANDARD_DEVIATION 18.42 • n=90 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
Weight
PP
|
77.6 kg
STANDARD_DEVIATION 18.44 • n=25 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
79.9 kg
STANDARD_DEVIATION 17.86 • n=41 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
79.0 kg
STANDARD_DEVIATION 17.97 • n=66 Participants • Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI
ITT
|
29.6 kg/m^2
STANDARD_DEVIATION 5.94 • n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
29.4 kg/m^2
STANDARD_DEVIATION 6.56 • n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
29.5 kg/m^2
STANDARD_DEVIATION 6.24 • n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI
PP
|
29.0 kg/m^2
STANDARD_DEVIATION 6.10 • n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
29.5 kg/m^2
STANDARD_DEVIATION 6.37 • n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
29.3 kg/m^2
STANDARD_DEVIATION 6.37 • n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
ITT · Underweight (<18.5)
|
0 Participants
n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
ITT · Normal (18.5-24.9)
|
10 Participants
n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
15 Participants
n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
25 Participants
n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
ITT · Overweight (25-29.9)
|
11 Participants
n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
9 Participants
n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
20 Participants
n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
ITT · Class 1 Obesity (30-34.9)
|
13 Participants
n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
12 Participants
n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
25 Participants
n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
ITT · Class 2-3 Obesity (≥35)
|
8 Participants
n=42 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
10 Participants
n=47 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=89 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
PP · Underweight (<18.5)
|
0 Participants
n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
1 Participants
n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
PP · Normal (18.5-24.9)
|
6 Participants
n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
12 Participants
n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
PP · Overweight (25-29.9)
|
9 Participants
n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
9 Participants
n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
18 Participants
n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
PP · Class 1 Obesity (30-34.9)
|
5 Participants
n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
10 Participants
n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
15 Participants
n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
|
BMI, categorical
PP · Class 2-3 Obesity (≥35)
|
5 Participants
n=25 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
9 Participants
n=41 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
14 Participants
n=66 Participants • BMI could not be calculated for one ITT subject whose height was not recorded. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success.
|
PRIMARY outcome
Timeframe: End of procedure, 1 per participantPopulation: Intent-to-Treat (ITT) includes all randomized subjects. Per-Protocol (PP) excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.
Any forward movement of the needle following puncture of the skin, counted until confirmation of spinal canal access can be assessed.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Number of Insertion Attempts
ITT
|
1.8 insertions
Standard Deviation 0.26
|
2.2 insertions
Standard Deviation 0.3
|
|
Number of Insertion Attempts
PP
|
1.2 insertions
Standard Deviation 0.66
|
2.1 insertions
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data recorded for the related outcome measure (insertions).
A case that does not require any reinsertions, but can include any number of redirections.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of First-insertion Success
ITT
|
25 Participants
|
25 Participants
|
|
Incidence of First-insertion Success
PP
|
21 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.
Any forward movement of the needle in a new direction not preceded by withdrawal from the skin, counted until confirmation of spinal canal access can be assessed.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Number of Redirections
ITT
|
4.5 redirections
Standard Deviation 5.60
|
5.8 redirections
Standard Deviation 8.44
|
|
Number of Redirections
PP
|
2.5 redirections
Standard Deviation 3.14
|
5.2 redirections
Standard Deviation 8.31
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions and redirections).
Any forward movement of the needle, calculated as the sum of insertions and redirections.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Number of Passes
ITT
|
6.4 passes
Standard Deviation 6.66
|
8.0 passes
Standard Deviation 9.78
|
|
Number of Passes
PP
|
3.8 passes
Standard Deviation 3.49
|
7.3 passes
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the related outcome measures (insertions, redirections).
A case that does not require reinsertions or redirections.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of First-pass Success
ITT
|
10 Participants
|
9 Participants
|
|
Incidence of First-pass Success
PP
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.
Evaluated using a 10-point Numeric Pain Rating Scale, where 1 is equivalent to no pain and 10 is equivalent to the worst possible pain.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Subject Discomfort During Landmarking
ITT
|
2.0 score on a scale
Standard Deviation 2.17
|
1.9 score on a scale
Standard Deviation 2.43
|
|
Subject Discomfort During Landmarking
PP
|
1.5 score on a scale
Standard Deviation 1.66
|
1.5 score on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: End of procedure, 1 per subjectPopulation: ITT includes all randomized subjects. PP excludes subjects that did not receive the randomized method and/or achieve a procedure success. Number analyzed in each population refers to the subjects with data collected for the specific outcome measure.
Evaluated using a 1-5 point Numeric Rating Scale where 1 is equivalent to not at all confident and 5 equivalent to completely confident.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=46 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Provider Confidence With the Identified Insertion Site
ITT
|
3.6 score on a scale
Standard Deviation 1.43
|
4.2 score on a scale
Standard Deviation 0.97
|
|
Provider Confidence With the Identified Insertion Site
PP
|
4.0 score on a scale
Standard Deviation 1.24
|
4.2 score on a scale
Standard Deviation 0.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
Time from first touch of draped patient to identification of an insertion site; for VerTouch, this is the time from VerTouch device placement to movement of the applicator to the identified insertion site.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=25 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=41 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Localization Time
|
197.3 seconds
Standard Deviation 247.03
|
170.3 seconds
Standard Deviation 300.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
Time from retrieval of marker or local-anesthetic assembly until no further needle advancements are made.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=25 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=41 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Insertion Time
|
303.5 seconds
Standard Deviation 600.79
|
301.8 seconds
Standard Deviation 390.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
From positioning of the patient to removal of the drape from the subject's back.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=25 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=41 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Total Procedure Time
|
19.3 minutes
Standard Deviation 16.43
|
20.5 minutes
Standard Deviation 28.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: PP excludes subjects that did not receive the randomized method and/or achieve a procedure success.
Number of times the needle contacts bone, counted until confirmation of spinal canal access can be assessed.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=25 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=41 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Bone Contacts
|
2.0 contacts
Standard Deviation 6.04
|
2.9 contacts
Standard Deviation 4.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case that results in puncture of the dura when it is not intended (i.e., in an epidural procedure).
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=45 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Unintended Dural Puncture
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case in which paresthesia is experienced during needle insertion.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=45 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Paresthesia During Needle Insertion
|
8 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case that results in visible blood aspiration.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=45 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Traumatic Tap
|
1 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case in which the provider cannot perform the procedure at the bedside and refers the subject to radiology for the procedure to be completed under fluoroscopic guidance.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=45 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Referral to Radiology
|
4 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case that the provider opts to complete using epidural anesthesia instead of spinal anesthesia.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=45 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Conversion From Spinal to Epidural
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Follow up, 3±2 days after procedure, 1 per subjectPopulation: All randomized subjects with data for the safety endpoint.
A case that results in the patient experiencing one or more headache of any level of severity after the procedure and/or at follow-up.
Outcome measures
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=40 Participants
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=46 Participants
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Incidence of Post-dural Puncture Headache
|
9 Participants
|
16 Participants
|
Adverse Events
Experimental Group 1: Tactile Imaging (VerTouch)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: Control (Palpation)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group 1: Tactile Imaging (VerTouch)
n=42 participants at risk
VerTouch used to identify and mark, or begin placement of a needle, at an insertion site.
Tactile Imaging (VerTouch): VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner.
|
Group 2: Control (Palpation)
n=48 participants at risk
Palpation used to identify and mark an insertion site.
Control (palpation): Control, palpation used to identify and mark an insertion site.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • Number of events 1 • 3±2 days
|
0.00%
0/48 • 3±2 days
|
|
Blood and lymphatic system disorders
Hemorrhage
|
2.4%
1/42 • Number of events 1 • 3±2 days
|
0.00%
0/48 • 3±2 days
|
|
Musculoskeletal and connective tissue disorders
Back and Shoulder Pain
|
0.00%
0/42 • 3±2 days
|
2.1%
1/48 • Number of events 1 • 3±2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place