NCT01939106

One Piece Drainable Pouch in Subjects With an Ileostomy

A Single Center Study to Assess the Safety and Performance of a One Piece Drainable Pouch in Subjects With an Ileostomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.

Detailed description

This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.

Conditions

• Ileostomy

Interventions

Type	Name	Description
DEVICE	One Piece Drainable Pouch

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-09-11
• Last updated: 2013-09-11

Locations

1 site across 1 country: United States