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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

September 29, 2008
July 29, 2013
June 2004
August 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00762047 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fecal Incontinence
  • Device: Durasphere FI
    Durasphere Injection
  • Device: Sham
    Sham injection with anesthesia
  • Experimental: Durasphere
    Intervention: Device: Durasphere FI
  • Sham Comparator: Sham
    Intervention: Device: Sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
June 2009
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00762047
P1004
No
Carbon Medical Technologies
Carbon Medical Technologies
Not Provided
Not Provided
Carbon Medical Technologies
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP