Sepraspray™ Laparoscopic Myomectomy Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy|
- The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. [ Time Frame: 30 Days post surgery ] [ Designated as safety issue: Yes ]
- Efficacy endpoints are on adhesion formation and will include the success the success criterion for the individual patients as either anterior or posterior uterus free of dense adhesions. [ Time Frame: Until end of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Sepraspray applied directly to both sides of the uterus, Fallopian tubes, and ovaries (or opposing sites if not possible to apply directly). Sepraspray was applied via a sterile cannula at a tissue concentration of approximately 5 mg/cm^2.
No Intervention: Control
No anti-adhesion treatment was used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624390
|United States, Illinois|
|Naperville, Illinois, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Texas|
|Austin, Texas, United States|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|