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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02208258
Other study ID # CON/2013/FI003
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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