Trials / Completed
CompletedNCT00624390
Sepraspray™ Laparoscopic Myomectomy Study
A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sepraspray |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-02-27
- Last updated
- 2016-12-14
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00624390. Inclusion in this directory is not an endorsement.