WithdrawnNCT02208258Updated Jan 29, 2016

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

An interventional study of Consure 120 Stool Management System in Fecal Incontinence, sponsored by Consure Medical Pvt. Ltd.. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Consure Medical Pvt. Ltd. · Not applicable, Interventional, and Supportive care

Why this study was withdrawn

Hospital had initiated a conflicting study, hence the study was terminated.

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Fecal Incontinence

Browse trials for

Fecal Incontinence 312

Keywords

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

In context

Fecal Incontinence

312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.

Browse Fecal Incontinence studies →

Lead sponsor

This is the only study on the registry with Consure Medical Pvt. Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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).

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 0 participants (actual)

Interventions

DeviceConsure 120 Stool Management System
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
Also known as: Consure 120 SMS

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Sharp HealthCare
San Diego, California 92123, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02208258
Lead sponsor: Consure Medical Pvt. Ltd.
Responsible party: Sponsor
First posted: Aug 5, 2014
Start date: Sep 2014
Primary completion: Oct 2014
Completion: Oct 2014
Last update: Jan 29, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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