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: January 10, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 29, 2008
Last Updated Date	January 10, 2012
Start Date ^ICMJE	June 2004
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 29, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00762047 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Official Title ^ICMJE	Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Fecal Incontinence
Intervention ^ICMJE	Device: Durasphere FI Durasphere Injection Device: Sham Sham injection with anesthesia
Study Arm (s)	Experimental: Durasphere Intervention: Device: Durasphere FI Sham Comparator: Sham Intervention: Device: Sham
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	90
Completion Date	June 2009
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00762047
Other Study ID Numbers ^ICMJE	P1004
Has Data Monitoring Committee	No
Responsible Party	Carbon Medical Technologies
Study Sponsor ^ICMJE	Carbon Medical Technologies
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Carbon Medical Technologies
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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