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

NCT01090739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2016-08-26

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

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.

Sponsors & Collaborators

  • ASTORA Women's Health

    lead INDUSTRY

Principal Investigators

  • Anders Mellgren, MD, PhD · University of Illinois at Chicago

  • Dee Fenner, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-11-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090739 on ClinicalTrials.gov