MRI Outcomes of VersaWrap Nerve Protector Following Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VersaWrap Nerve Protector.
- Who it may be relevant to
- Registry conditions: Lumbar Decompression. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
Overview
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
- Device VersaWrap Nerve Protector
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues
Primary outcome measures
- MRI [Time frame: 4 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Austin Neurosurgeons — Austin
Identifiers
NCT: NCT06942819 · TP-081