Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VersaWrap | All enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VersaWrap Nerve Protector | Device | VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI | Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns | 4 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who meet the following criteria and none of the exclusion will be enrolled in the study. A patient is considered enrolled upon successful placement of VersaWrap during the surgical procedure. If the surgeon decides intra-operatively not to utilize VersaWrap then the patient will be considered a screen failure.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Neurosurgeons | Austin | Texas | 78746 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided