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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02208258

Enrollment

Registered

2014-08-05

Start date

2014-09-30

Completion date

2014-10-31

Last updated

2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

fecal incontinence, consure medical, semi formed stool, stool management system

Brief summary

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.

Interventions

DEVICEConsure 120 Stool Management System

Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Visual confirmation that fecal material is diverted into the external collection bag through the device.	120 +/- 8 hours	Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.	120 +/- 8 hours	Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
Number of hours for which the device stays on without change or removal.	120 +/- 8 hours	Quantitative measure of duration of device use. The cause of the change or removal will be documented.

Secondary

Measure	Time frame	Description
Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.	120 +/- 8 hours	Yes or No response from visual observation of any bleeding on the external periphery of the device.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026