Trials / Unknown
UnknownNCT01014494
Adaprev in Digital Flexor Tendon Repair
A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Renovo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Adaprev | Class III Medical Device |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2011-11-01
- Completion
- 2011-12-01
- First posted
- 2009-11-17
- Last updated
- 2010-12-09
Locations
9 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01014494. Inclusion in this directory is not an endorsement.