NCT06942819

MRI Outcomes of VersaWrap Nerve Protector Following Surgery

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: Research Source · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lumbar Decompression

Interventions

Type	Name	Description
DEVICE	VersaWrap Nerve Protector	VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues

Timeline

• Start date: 2025-08-08
• Primary completion: 2025-12-01
• Completion: 2027-05-01
• First posted: 2025-04-24
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study