Trials / Suspended
SuspendedNCT00865488
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- OMRIX Biopharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.
Detailed description
Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ADHEXIL | Adhesions prevention |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2010-02-01
- Completion
- 2010-04-01
- First posted
- 2009-03-19
- Last updated
- 2009-12-23
Locations
5 sites across 5 countries: United States, Germany, Mexico, Russia, Spain
Source: ClinicalTrials.gov record NCT00865488. Inclusion in this directory is not an endorsement.