NCT01935999

One Piece Closed Pouch in Subjects With a Colostomy

A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Colostomy

Interventions

Type	Name	Description
DEVICE	One piece closed pouch	A one piece closed pouch for the collection of stool from a colostomy stoma

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-09-05
• Last updated: 2013-09-06

Locations

1 site across 1 country: United States