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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Leiomyoma Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00891657
Study type Interventional
Source Integra LifeSciences Corporation
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date May 2009
View Details
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