MRI Outcomes of VersaWrap Nerve Protector Following Surgery

August 18, 2025 updated by: Research Source

Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery

The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.

Study Type

Observational

Enrollment (Estimated)

26

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78746
        • Austin Neurosurgeons

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the following criteria and none of the exclusion will be enrolled in the study. A patient is considered enrolled upon successful placement of VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize VersaWrap then the patient will be considered a screen failure.

Description

Inclusion Criteria:

  1. Patients aged ≥18 and ≤65 at time of surgery
  2. Patients undergoing lumbar decompression bilaterally at one level from L4-S1
  3. Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.

Exclusion Criteria:

  1. Non-English speaking
  2. Known allergy or sensitivity to citrate, alginate or hyaluronate
  3. Known allergy or sensitivity to MRI contrast dye
  4. Known to experience claustrophobia
  5. Pregnant or breastfeeding at time of surgery
  6. Incarcerated at time of surgery
  7. Prior lumbar surgery at the index level
  8. Conjunction device use at index level (i.e., Barricade)*
  9. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol *Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VersaWrap
All enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure
Device: VersaWrap Nerve Protector
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: 4 months
Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns
4 months

Collaborators and Investigators

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

Sponsor

Research Source

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)

August 8, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP-081

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.

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