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Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study

Primary Purpose

Fecal Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ForConti device
Sponsored by
ForConti Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fecal Incontinence

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. Patient has the ability to self-manage insertion and removal of the device.
  2. Patient age is between 18 and 85 years old
  3. History of fecal incontinence for at least 6 months
  4. A minimum of four incontinence episodes during the 2-week baseline period
  5. Patient colon surveillance must be in compliance with the Ministry of Health National Program American Cancer Society colon for the Early Detection of Colorectal Cancer screening guidelines.
  6. Patient comprehends study meaning & is capable of carrying out study duties.

Exclusion Criteria:

  1. Spinal cord injury or other major neurological diagnosis
  2. Known life threatening disease such as cancer, immune deficiency state
  3. Significant cardiac arrhythmia
  4. Pregnant or Breastfeeding
  5. Inflammatory bowel disease
  6. Anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day)
  7. Anorectal diseases: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding
  8. Chronic pelvic pain
  9. Rectal surgery in past 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ForConti device

    Arm Description

    Use the device up to 12 hours/day for 4 weeks

    Outcomes

    Primary Outcome Measures

    Adverse events
    4 weeks of use and 2 weeks follow-up

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    June 21, 2018
    Sponsor
    ForConti Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02865291
    Brief Title
    Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study
    Official Title
    Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ForConti Medical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The ForConti Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti FIMS is designed for self-insertion to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum. The purpose of the study is to demonstrate that the ForConti FIMS is safe and that it improves management of fecal incontinence and improves quality of life. Patients will record bowel events in a daily diary over a 6 week period, which includes 2 weeks without using the device followed by 4 weeks using the device. Quality of Life questionnaire will be completed before and after use of the device. Stool leakage data collected when the device is not being used will be compared with data collected during use of the device to determine effectiveness.
    Detailed Description
    There are several devices for treating bowel incontinence. However, available devices have limited success. Sphincter bulking agents and electrical stimulation did not demonstrate effectiveness in clinical studies. Anal plugs did show some effectiveness but are associated with discomfort and pain. Hence, patients prefer not to use them. The main reason for pain and discomfort with the current available anal plugs is the plug location within the anus below the dentate line. This part of the anus which is highly sensitive it causes discomfort and pain to the user. The advantage of the ForConti device is that it is designed to be located at a more inner section of the anal canal, above the dentate line, which is much less sensitive thus does not cause discomfort to the user. This is a prospective, feasibility, non-randomized, single-arm, self-controlled study for preliminary safety and effectiveness. Total duration of the study for each patient will be 8 weeks, including follow-up. The study will be conducted on up to 20 patients suffering from accidental bowel leakage due to bowel incontinence and who meet all of the inclusion criteria and none of the exclusion criteria. Following first 5 cases, interim preliminary safety analysis was conducted and a report submitted to Ministry of Health for approval to continue the study. Approval was granted. Primary Safety: No device related serious adverse events. Secondary Safety: Minimal rate of device or procedure related adverse events (intra and post-operative complications) in the treatment or in the follow-up periods. Effectiveness: Demonstrate the effectiveness of the system by: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL, FI episodes) Determined by Comparing Active Weeks to Control Weeks Results as measured by Daily Diary Recordings. Active Weeks are the 3rd and 4th week of study treatment period and the Control Weeks are the baseline 2 weeks assessment period before starting treatment. Other Measurements: Usability: Evaluation of SUS Scores Quality of Life: Recording and Evaluation of a validated symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire Number of incontinence days while using the device during the two-week assessment period, as compared to the baseline two-week assessment period. The ForConti FIMS includes 2 main parts: the inserted part and the insertion system. The inserted part includes a balloon and a pulling string and the insertion system includes the applicator, plunger and the inflator. The balloon is a flexible biocompatible, silicone-based, oval-shaped, furled component. It is designed to be located in the rectum by an applicator and to be filled with a pre-determined amount of air to gain its final shape. The silicone surface is equipped with silicone gags which provide better sustainability in the rectum.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fecal Incontinence

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ForConti device
    Arm Type
    Experimental
    Arm Description
    Use the device up to 12 hours/day for 4 weeks
    Intervention Type
    Device
    Intervention Name(s)
    ForConti device
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    4 weeks of use and 2 weeks follow-up
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. Patient has the ability to self-manage insertion and removal of the device. Patient age is between 18 and 85 years old History of fecal incontinence for at least 6 months A minimum of four incontinence episodes during the 2-week baseline period Patient colon surveillance must be in compliance with the Ministry of Health National Program American Cancer Society colon for the Early Detection of Colorectal Cancer screening guidelines. Patient comprehends study meaning & is capable of carrying out study duties. Exclusion Criteria: Spinal cord injury or other major neurological diagnosis Known life threatening disease such as cancer, immune deficiency state Significant cardiac arrhythmia Pregnant or Breastfeeding Inflammatory bowel disease Anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day) Anorectal diseases: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding Chronic pelvic pain Rectal surgery in past 6 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Beer-Gabel, MD
    Organizational Affiliation
    Sheba Medical Center
    First Name & Middle Initial & Last Name & Degree
    Josef Lysi, MD
    Organizational Affiliation
    Shaheed Ziaur Rahman Medical College

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Effectiveness Evaluation of the ForConti Fecal Management System - Pilot Study

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