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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762047
Recruitment Status : Terminated
First Posted : September 30, 2008
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: Durasphere FI Device: Sham Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
Study Start Date : June 2004
Primary Completion Date : August 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Durasphere Device: Durasphere FI
Durasphere Injection
Sham Comparator: Sham Device: Sham
Sham injection with anesthesia

Primary Outcome Measures :
  1. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score [ Time Frame: 6 month ]
  2. Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere. [ Time Frame: Throughout study ]
  3. The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score [ Time Frame: 12 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Additional Information:
Responsible Party: Carbon Medical Technologies Identifier: NCT00762047     History of Changes
Other Study ID Numbers: P1004
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: January 2012

Keywords provided by Carbon Medical Technologies:
Fecal Incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases