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

Carbon Medical Technologies

Status and phase: Terminated; Phase 2

Conditions: Fecal Incontinence

Treatments: Device: Durasphere FI; Device: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762047

P1004

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Durasphere

Experimental group

Treatment:

Device: Durasphere FI

Sham

Sham Comparator group

Treatment:

Device: Sham