Status:
ENROLLING_BY_INVITATION
MRI Outcomes of VersaWrap Nerve Protector Following Surgery
Lead Sponsor:
Research Source
Conditions:
Lumbar Decompression
Eligibility:
All Genders
18-65 years
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 decompr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06942819
Start Date
August 8 2025
End Date
May 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
Austin Neurosurgeons
Austin, Texas, United States, 78746