Trials / Terminated
TerminatedNCT05343143
NeuraGen 3D Pilot Study
An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.
Detailed description
The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeuraGen 3D Nerve Guide Matrix | Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps. |
Timeline
- Start date
- 2022-05-15
- Primary completion
- 2023-07-11
- Completion
- 2024-05-13
- First posted
- 2022-04-25
- Last updated
- 2024-05-16
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05343143. Inclusion in this directory is not an endorsement.