A Prospective, Safety and Efficacy Cohort Study of Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse Repair
Sponsor: |
Astora Women's Health |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ4553 |
Contact: |
Cara Grimes: 212-305-1107 / clg2173@columbia.edu |
The objective of this research study is to compare the treatment success rates and safety of two surgical treatment options: Native Tissue Repair and the Elevate Prolapse Repair System. You maychoose to participate in this research when you and your doctor have determined which surgical treatment option is right for you. The Elevate Prolapse Repair System is an FDA-cleared medicaldevice which has been successfully used since 2009 as a treatment to repair pelvic organ prolapse in women. The FDA is requesting post market studies to compare these two treatment options.
This study is closed
Investigator
Cara Grimes, MD, FACOG
Do you suffer from Pelvic Organ Prolapse and require surgical treatment? |
Yes |
No |