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A study to evaluate the clinical and health-economic effectiveness of a novel device for faecal management in bed-ridden patients with little to no bowel control

Phase 4
Conditions
Health Condition 1: null- Bedridden patients with fecal incontinence
Registration Number
CTRI/2017/02/007831
Lead Sponsor
Consure Medical Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
70
Inclusion Criteria

Male and female patients, more than 18 years of age who have liquid to semi-formed stool

Non-ambulatory, hospitalized patients

History of passage of at least 1 stool in past 24 hours

Patient or a legal representative of the patient gives written consent for the study

Exclusion Criteria

Patients enrolled in another clinical study or trial will be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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