NCT06942819Enrolling By InvitationNot Applicable
Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
Research Source1 site in 1 country26 target enrollmentStarted: August 8, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- MRI
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
MRI
Time Frame: 4 months
Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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