At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Randomized Trial Comparing Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
In Brief
A clinical study evaluating Vertessa® Lite Y mesh, Restorelle® Y mesh, and 2 other interventions for Vaginal Vault Prolapse. Completed, enrolled 106 participants across 1 site.
Detailed Summary
This is a randomized clinical trial to compare outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the treatment of vaginal vault prolapse
Study Details
Timeline
Interventions
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.
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.
The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation
The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation