Acell

Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders

Acell [NCT02021279]

Description:  The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.


Device: MatriStem Pelvic Floor Matrix
Procedure: native tissue repair

Primary Investigator: Karram

Drug/Device Information
Assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse
MatriStem Pelvic Floor Matrix is a surgical mesh sheet constructed from porcine urinary bladder matrix which is resorbed and replace by host-derived site-appropriate tissue
Nonrandomized
ACell Inc.