NCT01090739

Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence

An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.

Detailed description

This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist. This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	TOPAS Treatment for Fecal Incontinence	The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-11-01
• Completion: 2016-04-01
• First posted: 2010-03-22
• Last updated: 2016-08-26
• Results posted: 2016-08-26

Locations

14 sites across 1 country: United States