Sepraspray™ Laparoscopic Myomectomy Study
Not Applicable
Completed
- Conditions
- Laparoscopic Myomectomy
- Interventions
- Device: Sepraspray
- Registration Number
- NCT00624390
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 41
Inclusion Criteria
- The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.
Exclusion Criteria
- Pregnant/lactating women.
- The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
- The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sepraspray Sepraspray 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.
- Primary Outcome Measures
Name Time Method The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage. 30 Days post surgery 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. Until end of study
- Secondary Outcome Measures
Name Time Method