MRI Outcomes of VersaWrap Nerve Protector Following Surgery
NCT ID: NCT06942819
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
26 participants
OBSERVATIONAL
2025-08-08
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VersaWrap
All enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure
VersaWrap Nerve Protector
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues
Interventions
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VersaWrap Nerve Protector
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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Research Source
NETWORK
Responsible Party
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Locations
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Austin Neurosurgeons
Austin, Texas, United States
Countries
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Other Identifiers
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TP-081
Identifier Type: -
Identifier Source: org_study_id
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