Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

NACompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

September 18, 2018

Primary Completion Date

December 19, 2023

Study Completion Date

December 19, 2023

Conditions
Vaginal Vault Prolapse
Interventions
DEVICE

Vertessa® Lite Y mesh

Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive.

DEVICE

Restorelle® Y mesh

Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive.

PROCEDURE

Laparoscopic sacrocolpopexy

The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation

PROCEDURE

Robotic assisted laparoscopic sacrocolpopexy

The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation

Trial Locations (1)

44195

Cleveland Clinic, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER

NCT03681223 - Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy | Biotech Hunter | Biotech Hunter