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

NCT02208258 | Withdrawn

• 1 other identifier: CON/2013/FI003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  120 +/- 8 hours

Secondary Outcomes (1)

• 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

Interventions

Consure 120 Stool Management System DEVICE

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

Also known as: Consure 120 SMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Consure Medical Pvt. Ltd.: lead

Study Sites (1)

Sharp HealthCare

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)