One Piece Drainable Pouch in Subjects With an Ileostomy

Phase 2

Completed

• Conditions: Ileostomy
• Interventions: Device: One Piece Drainable Pouch

• Registration Number: NCT01939106
• Lead Sponsor: ConvaTec Inc.

Brief 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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-07-29
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Piece Drainable Pouch	One Piece Drainable Pouch	This is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma

Primary Outcome Measures

Name	Time	Method
Safety	Study duration will be 10 days	To assess the condition of the peristomal skin and stoma and number and frequency of adverse events

Secondary Outcome Measures

Name	Time	Method
Performance/Efficacy	The study will be for 10 days	To assess ease of use including ease of application and removal, comfort and security along with wear time

Trial Locations

Locations (1)

Independent Nurse Consultant LLC; 🇺🇸 Tucson, Arizona, United States