Trials / Completed
CompletedNCT01849458
BioFiber Scaffold Post-Market Observational Study
BioFiber and BioFiber-CM Absorbable Biologic Scaffold for Soft Tissue Repair and Reinforcement Post-Market Surveillance Clinical Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Stryker Trauma and Extremities · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
Detailed description
Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioFiber | Subjects implanted with BioFiber or BioFiber-CM Scaffold |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2013-05-08
- Last updated
- 2017-06-22
- Results posted
- 2017-06-22
Locations
3 sites across 2 countries: United States, France
Source: ClinicalTrials.gov record NCT01849458. Inclusion in this directory is not an endorsement.