Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study

CompletedOBSERVATIONAL
Enrollment

31

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Pelvic Organ Prolapse (POP)
Interventions
DEVICE

Restorelle Direct Fix A&P

Restorelle Direct Fix A\&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.

Trial Locations (6)

21237

MedStar Health Research Institute at Baltimore, Baltimore

23502

The Group for Women, Norfolk

37067

Center for Pelvic Health, Franklin

49503

Female Pelvic Medicine & Urogynecology Institute of MI, Grand Rapids

65340

Central Missouri Women's Healthcare, Marshall

98043

Integrity Medical Research, LLC, Mountlake Terrace

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Coloplast A/S

INDUSTRY