A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Primary Purpose
Fecal Incontinence
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Durasphere FI
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Durasphere
Sham
Arm Description
Outcomes
Primary Outcome Measures
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Secondary Outcome Measures
Full Information
NCT ID
NCT00762047
First Posted
September 29, 2008
Last Updated
July 29, 2013
Sponsor
Carbon Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00762047
Brief Title
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Official Title
Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carbon Medical Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durasphere
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Durasphere FI
Intervention Description
Durasphere Injection
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham injection with anesthesia
Primary Outcome Measure Information:
Title
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Time Frame
6 month
Title
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
Time Frame
Throughout study
Title
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Links:
URL
http://carbonmed.com
Description
Related Info
Learn more about this trial
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
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