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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06942819

Enrollment

Registered

2025-04-24

Start date

2025-08-08

Completion date

2027-05-01

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Decompression

Keywords

VersaWrap, Decompression

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.

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.

Interventions

DEVICEVersaWrap Nerve Protector

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026