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VerTouch Device: A Prospective Randomized Controlled Trial

NCT04630171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-09-12

Study results available
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Summary

This study will compare the VerTouch device to palpation and ultrasound (US) techniques used to identifying the anatomic landmarks and optimal location for neuraxial access. This trial of the VerTouch device will be compared to the gold standard of palpation and the commonly cited US techniques.

Conditions

Interventions

DEVICE

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

DEVICE

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

OTHER

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

Sponsors & Collaborators

Principal Investigators

  • Mahesh Vaidyanathan, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-11-28
Completion
2023-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630171 on ClinicalTrials.gov