MRI Outcomes of VersaWrap Verve Protector Following Surgery

Research Source

Status: Invitation-only

Conditions: Lumbar Decompression

Treatments: Device: VersaWrap Nerve Protector

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06942819

TP-081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 1 patient group

VersaWrap

Description:

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

Treatment:

Device: VersaWrap Nerve Protector