A Randomized, Masked Patient, Independent Reviewer, Multi-Center Pilot Study to Evaluate the Feasibility of Sepraspray™ Adhesion Barrier in Laparoscopic Myomectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Myomectomy
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 41
- Primary Endpoint
- The safety endpoints will include the type and incidence of AEs, vital signs, wound healing, laboratory examinations, and medication usage.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
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