Safety and Effectiveness Evaluation of the ForConti Contix Fecal Incontinence Management System (FIMS)

NCT03813251 | Unknown FDA Device

• 1 other identifier: CD-14-002
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ForConti Contix Fecal Incontinence Management System (FIMS) is indicated for the management of accidental bowel leakage due to bowel incontinence. The ForConti Contix FIMS is designed to seal and help prevent the involuntary leakage of stool, liquids and gases from the rectum. ForConti Contix FIMS is for an individual with fecal incontinence that has impaired quality of life, is responsive and mentally capable to participate in their own treatment. This study is designed to evaluate the safety and effectiveness of the ForConti Contix FIMS for its intended use utilizing a baseline period of 2 weeks followed by an on-device period of using the device for 4 weeks and completed with a followup period of 2 weeks.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (2)

• Number of device related serious adverse events

  Number of device related serious adverse events

  6 weeks (4 weeks of use and 2 weeks follow-up)

• Rate of subjects who improved by 50% or more in ABL (FI episodes) during the on-device period as compared to the baseline period.

  ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.

  8 weeks (2 weeks baseline, 4 weeks of use and 2 weeks follow-up)

Secondary Outcomes (2)

• Rate of device or procedure related adverse events in the treatment or in the follow-up periods.

  6 weeks (4 weeks of use and 2 weeks follow-up)

• Change in mean scores on subject-reported outcomes related to symptom-specific Fecal Incontinence Quality of Life (FIQoL) Questionnaire.

  6 weeks (2 weeks baseline, 4 weeks of use )

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

ForConti Contix Fecal Incontinence Management System (FIMS)

Device: ForConti Contix Fecal Incontinence Management System (FIMS)

Interventions

ForConti Contix Fecal Incontinence Management System (FIMS) DEVICE

Use the device for up to 12 hours per use for 4 weeks

Assigned Interventions

Eligibility Criteria

• Age: 22 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. Patient has the ability to self-manage insertion and removal of the device
• Patient age is between 22 and 85 years old
• Patient has history of fecal incontinence for at least 6 months
• Patient has a minimum of four incontinence episodes during the 2-week baseline period
• Patient colon surveillance complies with National Program/Guidelines for the Early Detection of Colorectal Cancer
• Patient comprehends study meaning and is capable of carrying out study duties
• If the candidate is currently prescribed medication per os or per rectum for bowel control, treatment has been administered for at least 4 weeks without a change in treatment regimen or dose, and the candidate agrees to continue the treatment without changes for the duration of the study

You may not qualify if:

• Patient had spinal cord injury or other major neurological diagnosis
• Patient has known life threatening disease such as cancer, immune deficiency state
• Patient has significant cardiac arrhythmia\*
• Patient has inflammatory bowel disease
• Patient is on anti-coagulants and anti-platelets treatment, except Aspirin (low dose: 75-100 mg/day)
• Patient has anorectal disease: perianal abscess, active fistula, fissure, hemorrhoids grade 3 or 4, Pruritus ani or rectal bleeding\*
• Patient has a clinically significant abnormality as visualized by sigmoidoscopy at the first visit
• Patient has pre-existing rectal pain or rectal bleeding
• Patient suffers from chronic pelvic pain
• Patient had rectal surgery in the past 6 months
• Patient has rectocele or other pelvic organ prolapse requiring surgery\*
• Patient has allergy to silicone or one of its components
• Patient has significant medical condition which may interfere with study participation
• Patient is currently participating in another clinical study.
• Female patient is pregnant or breastfeeding

Sponsors & Collaborators

• ForConti Medical: lead

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Stacy B Menees, MD

  University of Michigan, Department of Medicine, Division of Gastroenterology

  PRINCIPAL INVESTIGATOR

• William D Chey, MD

  University of Michigan, GI Physiology Laboratory

  PRINCIPAL INVESTIGATOR

• Lin Chang, MD

  David Gefen School of Medicine at UCLA, Division of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shay Leventhal Gabay, CA/RA Director

CONTACT

+972-4-647-2419; shay.leventhal@forconti-medical.com

Study Design

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

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: February 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share