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

NCT03813251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-23

No results posted yet for this study

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

Interventions

DEVICE

ForConti Contix Fecal Incontinence Management System (FIMS)

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

Sponsors & Collaborators

  • ForConti Medical

    lead INDUSTRY

Principal Investigators

  • Stacy B Menees, MD · University of Michigan, Department of Medicine, Division of Gastroenterology

  • William D Chey, MD · University of Michigan, GI Physiology Laboratory

  • Lin Chang, MD · David Gefen School of Medicine at UCLA, Division of Digestive Diseases

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-08-31
Completion
2019-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813251 on ClinicalTrials.gov