Trials / Completed
CompletedNCT03433391
Confirmatory Clinical Study of Oxiplex
Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- FzioMed · Industry
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded clinical study to assess the safety and effectiveness for the reduction of pain and symptoms following lumbar surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Oxiplex | Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier. |
| OTHER | Surgery Only | Single level partial discectomy as per standard of care procedures. |
Timeline
- Start date
- 2018-04-23
- Primary completion
- 2020-06-23
- Completion
- 2024-03-27
- First posted
- 2018-02-14
- Last updated
- 2024-06-27
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03433391. Inclusion in this directory is not an endorsement.