Trials / Unknown
UnknownNCT00544310
Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (planned)
- Sponsor
- OMRIX Biopharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Detailed description
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Anti adhesion agent | Adhesions prevention |
Timeline
- Start date
- 2008-01-01
- Completion
- 2008-10-01
- First posted
- 2007-10-16
- Last updated
- 2008-08-20
Locations
4 sites across 4 countries: United States, Germany, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00544310. Inclusion in this directory is not an endorsement.