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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Carbon Medical Technologies
ClinicalTrials.gov Identifier:
NCT00762047
First received: September 29, 2008
Last updated: July 29, 2013
Last verified: January 2012
  Purpose

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 Intervention Phase
Fecal Incontinence
Device: Durasphere FI
Device: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence

Resource links provided by NLM:


Further study details as provided by Carbon Medical Technologies:

Primary Outcome Measures:
  • The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: June 2004
Study Completion Date: June 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durasphere Device: Durasphere FI
Durasphere Injection
Sham Comparator: Sham Device: Sham
Sham injection with anesthesia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Carbon Medical Technologies
ClinicalTrials.gov Identifier: NCT00762047     History of Changes
Other Study ID Numbers: P1004
Study First Received: September 29, 2008
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Carbon Medical Technologies:
Fecal Incontinence

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

ClinicalTrials.gov processed this record on April 17, 2014