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

Fecal Incontinence Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02208258
• Other study ID #: CON/2013/FI003
• Status: Withdrawn
• Phase: N/A
• First received: August 1, 2014
• Last updated: January 28, 2016
• Start date: September 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Consure Medical Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Consure 120 Stool Management System
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.

Locations

Country	Name	City	State
United States	Sharp HealthCare	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Consure Medical Pvt. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	120 +/- 8 hours	Yes