A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence

Phase 2

Terminated

• Conditions: Fecal Incontinence
• Interventions: Device: Durasphere FI; Device: Sham

• Registration Number: NCT00762047
• Lead Sponsor: Carbon Medical Technologies

Brief Summary

The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.

The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2008-08
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Study Completion: 2009-06
• Status Verified: 2012-01
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• History of fecal incontinence;
• Incontinence episodes over a 14-day period;
• Eighteen years of age or older;

Exclusion Criteria

• Abnormalities of the external sphincter greater than 10 mm;
• Fibrosis of the tissue at the likely injection sites;
• Has a condition that could lead to significant postoperative complications
• Rectal varices;
• Cancer of the rectum or colon, undergoing active treatment;
• Crohn's disease or ulcerative colitis;
• Chronic diarrhea unmanageable by drugs and/or diet;
• Rectal bleeding;
• Pregnant or within one year postpartum.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durasphere	Durasphere FI	-
Sham	Sham	-

Primary Outcome Measures

Name	Time	Method
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score	6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.	Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score	12 month