Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.

Consure Medical

Status

Withdrawn

Conditions

Fecal Incontinence

Treatments

Device: Consure 120 Stool Management System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02208258

CON/2013/FI003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
Non-ambulatory, hospitalized patients.
History of passage of at least 1 stool in 24 hours.

Exclusion criteria

Patients with suspected or confirmed rectal mucosal impairment or pathology.
Patients with have undergone descending colon or rectal surgery within the preceding six months.
Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
Patients suspected to have impacted stool or is suffering from constipation.
Patients with confirmed pregnancy or suspected to be pregnant.
Patients that have planned MRI examination over the duration of the study.
Patients who have suffered recent cardiac arrest within the preceding 3 months.
Patients enrolled in another clinical study or clinical trial.
Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).