Ethicon, Inc. (Ethicon), is planning to complete clinical trial entitled “A Prospective, Multi-Center Study to Evaluate the Clinical Performance of the GYNECARE PROLIFT + M Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse” for GYNECARE PROLIFT+M Pelvic Floor Repair System by December 2011. The aim of the study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse. This trial is being conducted in Belgium, France, Germany, Netherlands.
The cohort, prospective, phase III trial is ongoing, but not recruiting participants. The study has estimated enrollment of 126 participants. The study director of this trial is David Robinson, MD Ethicon, Inc.
GYNECARE PROLIFT+M Pelvic Floor Repair System for tissue reinforcement has long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. It consists of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement.