Trial Outcomes & Findings for VerTouch Device: A Prospective Randomized Controlled Trial (NCT NCT04630171)
NCT ID: NCT04630171
Last Updated: 2025-09-12
Results Overview
Primary endpoint is the number of redirections of the needle
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
86 participants
Primary outcome timeframe
End of procedure
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
32
|
|
Overall Study
COMPLETED
|
28
|
26
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VerTouch Device: A Prospective Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
n=32 Participants
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
n=26 Participants
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
n=28 Participants
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.4 Years
n=99 Participants
|
34.3 Years
n=107 Participants
|
34.6 Years
n=206 Participants
|
34.3 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
30 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
BMI = Weight (kg) / Height (m)²
|
29.32 kg/m^2
n=99 Participants
|
31.6 kg/m^2
n=107 Participants
|
31.12 kg/m^2
n=206 Participants
|
30.58 kg/m^2
n=7 Participants
|
|
Height (in)
|
65.09 Inches
n=99 Participants
|
64.69 Inches
n=107 Participants
|
64.51 Inches
n=206 Participants
|
64.8 Inches
n=7 Participants
|
|
Weight (Kilograms)
|
80.01 Kilograms
n=99 Participants
|
85.2 Kilograms
n=107 Participants
|
83.5 Kilograms
n=206 Participants
|
84.04 Kilograms
n=7 Participants
|
PRIMARY outcome
Timeframe: End of procedurePrimary endpoint is the number of redirections of the needle
Outcome measures
| Measure |
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
n=32 Participants
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
n=26 Participants
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
n=28 Participants
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
|---|---|---|---|
|
Number of Redirections of the Needle
|
.72 Number of redirections of needle
Standard Deviation .9
|
2.81 Number of redirections of needle
Standard Deviation 3.7
|
2.35 Number of redirections of needle
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 24 hours.Secondary endpoint is the number of reinsertions of the needle.
Outcome measures
| Measure |
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
n=32 Participants
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
n=26 Participants
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
n=28 Participants
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
|---|---|---|---|
|
Number of Reinsertions of the Needle
|
.11 Number of needle insertions
Standard Deviation .3
|
.96 Number of needle insertions
Standard Deviation 1.5
|
.5 Number of needle insertions
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 24 hoursTotal neuraxial procedure time in minutes
Outcome measures
| Measure |
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
n=32 Participants
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
n=26 Participants
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
n=28 Participants
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
|
|---|---|---|---|
|
Total Procedure Time
|
8.66 Minutes
Standard Deviation 2.6
|
9.81 Minutes
Standard Deviation 4.1
|
7.88 Minutes
Standard Deviation 3.1
|
Adverse Events
Group 1: VerTouch for Labor Epidural or Spinal Anesthesia Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Ultrasound (US) for Labor Epidural or Spinal Anesthesia Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Control Group, Palpation for Labor Epidural or Spinal Anesthesia Procedure
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