A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
- Females, 18 years of age or older, of child-bearing potential.
- Subject has at least one myoma >= 3 cm.
- Pregnant or lactating females.
- Females undergoing prior open or closed myomectomy for treatment of myomas.
- Evidence of current active endometriosis or infection
- History of or active inflammatory bowel disease or pelvic inflammatory disease.
- Presence of a frozen pelvis, or hydrosalpinges.
Type of Study:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Number of Sites Adherent to the Uterus
The number of times an adhesion is attached to the uterus.
Outcome Time Frame:
8-12 weeks post myomectomy
Rudy Leon De Wilde, MD
Germany: Federal Institute for Drugs and Medical Devices
- Tissue Adhesions