Lumbar DecompressionNCT06942819
MRI Outcomes of VersaWrap Nerve Protector Following Surgery
An observational study of Lumbar Decompression, run by Research Source at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Decompression
- What is being tested?
- VersaWrap Nerve Protector
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
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.
Read the 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.
- Conditions
- Lumbar Decompression
- Being tested
- VersaWrap Nerve Protector
- Keywords
- VersaWrap, Decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VersaWrap Nerve ProtectorDevice
VersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues
| Study group | Role | What they receive |
|---|---|---|
| VersaWrap | All enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure Receives: Device: VersaWrap Nerve Protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start8 Aug 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar DecompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Source
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942819
- Sponsor's protocol ID
- TP-081
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
- ClinicalTrials.gov ID
- NCT06942819
- Acronym / sponsor ID
- TP-081
- Conditions
- Lumbar Decompression
- Keywords
- VersaWrap, Decompression
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Research SourceResearch network
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VersaWrap | – | Device: VersaWrap Nerve ProtectorAll enrolled patients will receive VersaWrap Nerve Protector prior to surgical closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VersaWrap Nerve ProtectorVersaWrap Nerve Protector is applied to the nerve root to protect the surrounding tissues | Device | VersaWrap |
Primary outcome
MRI
Time frame: 4 months
Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Decompression
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Enrolling by invitationObservational study
Pain After Microsurgical Decompression
LUMBAR STENOSIS
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Active, not recruiting
The NORDSTEN Study - Degenerative Spondylolisthesis
Lumbar Degenerative Spondylolisthesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Decompression, run by Research Source at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.