MRI Outcomes of VersaWrap Nerve Protector Following Surgery

NCT06942819 | Enrolling By Invitation FDA Device

• 1 other identifier: TP-081
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Decompression

Keywords

VersaWrap; Decompression

Outcome Measures

Primary Outcomes (1)

• MRI

  Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns

  4 months

Study Arms (1)

VersaWrap

All enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure

Device: VersaWrap Nerve Protector

Interventions

VersaWrap Nerve Protector DEVICE

VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues

VersaWrap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Non-English speaking
• Known allergy or sensitivity to citrate, alginate or hyaluronate
• Known allergy or sensitivity to MRI contrast dye
• Known to experience claustrophobia
• Pregnant or breastfeeding at time of surgery
• Incarcerated at time of surgery
• Prior lumbar surgery at the index level
• Conjunction device use at index level (i.e., Barricade)\*
• 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

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Austin Neurosurgeons

Austin, Texas, 78746, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: August 8, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)