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NCT02208258 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2016-01-29
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
Interventions
- DEVICE
-
Consure 120 Stool Management System
Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
Sponsors & Collaborators
-
Consure Medical Pvt. Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- United States
Study Locations
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