Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
NCT ID: NCT02208258
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-09-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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Consure 120 Stool Management System
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-ambulatory, hospitalized patients.
* History of passage of at least 1 stool in 24 hours.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Consure Medical Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Sharp HealthCare
San Diego, California, United States
Countries
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Other Identifiers
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CON/2013/FI003
Identifier Type: -
Identifier Source: org_study_id