Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy

This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.

Inclusion Criteria:

• Females, 18 years of age or older, of child-bearing potential.
• Subject has at least one myoma >= 3 cm.

Exclusion Criteria:

• 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.