VerTouch Device: A Prospective Randomized Controlled Trial

NCT04630171 | Completed Results FDA Device

• 1 other identifier: STU00213282
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Pregnancy; Pain

Keywords

Pregnancy; Neuraxial Anesthesia; Therapeutic Lumbar Puncture; Ultrasound; Labor epidural; Spinal Procedure

Outcome Measures

Primary Outcomes (1)

• Number of Redirections of the Needle

  Primary endpoint is the number of redirections of the needle

  End of procedure

Secondary Outcomes (2)

• Number of Reinsertions of the Needle

  24 hours.

• Total Procedure Time

  24 hours

Study Arms (3)

Group 1: VerTouch for labor epidural or spinal anesthesia procedure

EXPERIMENTAL

VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.

Device: Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure

Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure

ACTIVE COMPARATOR

Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.

Device: Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure

Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure

ACTIVE COMPARATOR

Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.

Other: Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure

Interventions

Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure DEVICE

Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia

Also known as: Group 1

Group 1: VerTouch for labor epidural or spinal anesthesia procedure

Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure DEVICE

Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia

Also known as: Group 2

Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure

Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure OTHER

Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia

Also known as: Group 3

Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18 years old and above
• Undergoing a neuraxial procedure

You may not qualify if:

• Non English speaking
• Plastic allergy
• Unable to provide written informed consent

Sponsors & Collaborators

• Northwestern University: lead
• Intuitap: collaborator

Study Sites (1)

Northwestern Memorial Hospital and Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Mahesh Vaidyanathan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to what procedure will be used to identify lumbar landmarks. All devices will be in the room with the operator of the devices.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: November 28, 2023
• Study Completion: November 29, 2023
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)