Restorelle® Mesh Versus Native Tissue Repair for Prolapse

What is the purpose of this trial?

The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.


Participation Guidelines

Ages: 18 years and older

Gender: Female only


Coloplast Corp.

Start Date: 10/12/2016

End Date: 04/30/2017

Last Updated: 02/22/2018

Study HIC#: 1606017923

Get Involved

For more information about this study, contact:
Luisa Coraluzzi
+1 203-785-2164
luisa.coraluzzi@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Richard Bercik

Principal Investigator

Sub-Investigators