Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Integra LifeSciences

Status: Completed

Conditions: Leiomyoma; Fibroid; Myoma

Treatments: Device: SprayShield™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891657

GYN-08-002

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

SprayShield™

Experimental group

Description:

SprayShield™

Treatment:

Device: SprayShield™

Control

No Intervention group

Description:

No adhesion barrier administered.