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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
Carbon Medical Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

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

    First Posted
    September 29, 2008
    Last Updated
    July 29, 2013
    Sponsor
    Carbon Medical Technologies
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    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

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

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