Laparoscopic Myomectomy
Conditions
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.
Interventions
DEVICESepraspray
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed