Safety and Efficacy of new Continent Ostomy Management System
- Conditions
- Health Condition 1: K508- Crohns disease of both small andlarge intestine
- Registration Number
- CTRI/2023/09/057389
- Lead Sponsor
- CRIMSON HEALTHCARE PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject is 18 years and older.
2.Subject has had end colostomy or end ileostomy for at least 1 month.
3.Subject has mental capacity to understand guidelines and feedback questionnaire.
4.Subject has no fistula around the stoma.
•Subject has been evaluated by the investigator to have a stoma and other conditions suitable for this study.
•Subject has successfully completed the preliminary evaluation stage conducted by the investigator. (Described later in the document)
•Subject signs and date the written informed consent form and indicates the understanding of the study procedures
Pregnant or breastfeeding women.
Suffering from fistula as examined by the investigator.
Receiving or have received within the past 2 months any therapies such as chemotherapy/radiation etc.
Subject has abdominal wall thickness greater than 40mm.
Participating in any other clinical study.
Inflammatory stoma/intestine.
Tendency of frequent stomal bleeding, diarrhea or constipation.
Peristomal hernia.
Stoma protrusion greater than 2 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method