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

Fecal Incontinence Clinical Trial

Official title:

Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00762047
• Other study ID #: P1004
• Status: Terminated
• Phase: Phase 2
• First received: September 29, 2008
• Last updated: July 29, 2013
• Start date: June 2004
• Est. completion date: June 2009

Study information

• Verified date: January 2012
• Source: Carbon Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: June 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Durasphere FI
Durasphere Injection
• Sham
Sham injection with anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carbon Medical Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score		6 month	No
Primary	Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.		Throughout study	Yes
Primary	The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score		12 month	No

External Links

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