VerTouch Device: A Prospective Randomized Controlled Trial

March 11, 2024 updated by: Mahesh Vaidyanathan, Northwestern University

Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures When Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial

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 palpatoin and the commonly cited US techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thousands of neuraxial procedures are completed daily with over 12,000 done at Prentice Women's hospital last year. These procedures are not without difficulty and complication. The gold standard of palpation and blind advancement of the needle toward the spine can result in multiple insertions of the needle into the skin and redirections of the trajectory of that needle after insertion to avoid the bones of the spine protecting the spinal column. These insertions and redirections are not only time consuming while the patient is in an uncommon position, but they also cause dis-comfort and possibly lasting pain days after the procedure. In addition to the patient dynamics, when anatomical or positioning issues result in difficult neuraxial procedures the common teaching is to attempt US guided access. Unfortunately, not many proceduralist are trained in this modality and the additional materials needed to perform the procedure with US take time to gather and further prolong the procedure. Additionally, though the cost of US technology is getting more reasonable, it is still rather expensive and a barrier to utilization by many facilities around the country and the world. Often, after many attempts, the proceduralist accepts failure of the procedure and refers the patient to the interventional radiology (IR) or pain medicine specialist for completion of the procedure using radiation to visualize the spine. Note, this is not an option for pregnant women who are not eligible for radiation due to fetal concerns.

The VerTouch device offers a non-invasive, untethered, and non-radiation producing device that allows for the visualization of the underlying structures of the spine to determine ideal needle placement for neuraxial procedures. The output on the screen can also be visualized by other providers or senior proceduralist for assistance with best course of action for the procedure. The device does not cause discomfort to the patient and does not require any additional materials to be functional.

Study participants will be recruited in two parallel cohorts (pregnant patients and non-pregnant patients). Pregnant patients tend to be healthy and without comorbidities, and the anesthesiologists who perform the neuraxial procedure tend to have significant experience. Non-pregnant patients tend to require neuraxial access for diagnostic or therapeutic purposes (i.e. not for the relief of labor pains), and therefore have comorbidities.

Labor & Delivery: Participants will be randomized to one of the three arms (palpation, US, or VerTouch).

Lumbar Puncture: Participants will be randomized to one of the three arms (palpation, US, or VerTouch).

This study has the potential to show that the VerTouch is more effective than palpation and as effective as US at defining the location for neuraxial procedure initiation and eventual success.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital and Prentice Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • Group 1
Active Comparator: 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.
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 Names:
  • Group 2
Active Comparator: 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.
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
Other Names:
  • Group 3
Experimental: Group 4: VerTouch for lumbar puncture procedure
VerTouch utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Device: Group #4: VerTouch utilized for identification of site for lumbar puncture procedure
Group #4: VerTouch utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
Other Names:
  • Group 4
Active Comparator: Group 5: Ultrasound (US) for lumbar puncture procedure
Ultrasound (US) utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Device: Group #5: Ultrasound (US) utilized for identification of site for lumbar puncture procedure
Ultrasound (US) utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
Other Names:
  • Group 5
Active Comparator: Group 6: Control group, palpation for lumbar puncture procedure
Control group, palpation utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Other: Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure
Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
Other Names:
  • Group 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of insertions of the needle
Time Frame: End of procedure
Primary endpoint is the number of insertions of the needle
End of procedure
Number of redirections of the needle
Time Frame: End of procedure
Primary endpoint is the number of redirections of the needle
End of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Intuitap

Investigators

  • Principal Investigator: Mahesh Vaidyanathan, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 29, 2023

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00213282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe