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

NCT02865291 | Unknown

• 1 other identifier: CD-14-001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Adverse events

  4 weeks of use and 2 weeks follow-up

  6 weeks

Study Arms (1)

ForConti device

EXPERIMENTAL

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

Device: ForConti device

Interventions

ForConti device DEVICE

ForConti device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ForConti Medical: lead

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mark Beer-Gabel, MD

  Sheba Medical Center

• Josef Lysi, MD

  Shaheed Ziaur Rahman Medical College

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share