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Clinical Trial Summary

A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.


Clinical Trial Description

Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01935999
Study type Interventional
Source ConvaTec Inc.
Contact
Status Completed
Phase Phase 2
Start date June 2013
Completion date July 2013

See also
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Completed NCT02362360 - Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy N/A
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Completed NCT02861443 - Irrigation of the Large Intestine in the Patients With Colostomy : Epidemiology and Quality of Life N/A
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