Back to resultsEfficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
Primary Purpose
Fecal Incontinence
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Consure 120 Stool Management System
Sponsored by
About this trial
This is an interventional supportive care trial for Fecal Incontinence focused on measuring fecal incontinence, consure medical, semi formed stool, stool management system
Eligibility Criteria
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).
Sites / Locations
- Sharp HealthCare
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02208258
First Posted
August 1, 2014
Last Updated
January 28, 2016
Sponsor
Consure Medical Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02208258
Brief Title
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Hospital had initiated a conflicting study, hence the study was terminated.
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consure Medical Pvt. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
fecal incontinence, consure medical, semi formed stool, stool management system
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Consure 120 Stool Management System
Other Intervention Name(s)
Consure 120 SMS
Intervention Description
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
Primary Outcome Measure Information:
Title
Visual confirmation that fecal material is diverted into the external collection bag through the device.
Description
Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
Time Frame
120 +/- 8 hours
Title
Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
Description
Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
Time Frame
120 +/- 8 hours
Title
Number of hours for which the device stays on without change or removal.
Description
Quantitative measure of duration of device use. The cause of the change or removal will be documented.
Time Frame
120 +/- 8 hours
Secondary Outcome Measure Information:
Title
Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.
Description
Yes or No response from visual observation of any bleeding on the external periphery of the device.
Time Frame
120 +/- 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Sharp HealthCare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
We'll reach out to this number within 24 hrs