Comparison Study of 3 Ostomy Products

Not Applicable

Completed

• Conditions: Ostomy

• Registration Number: NCT01691729
• Lead Sponsor: ConvaTec Inc.

Brief Summary

To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.

Detailed Description

The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Has an ostomy
• Is at least 18 years of age
• Has a stoma for at least 3 months
• Other than thier ostomy is considered to have a healthy/stable health
• Is able to take care of their stoma

Exclusion Criteria

• Known sensitivity to any of the ostomy devices or components
• Is undergoing chemotherapy or radiotherapy
• Has participated in a clinical study within the past 30 days
• Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Leakage & Wear Time	10 days	Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	10 days	Evaluation and comparison of the safety of three ostomy accessory products

Trial Locations

Locations (4)

Independent Nurse Consultants; 🇺🇸 Tucson, Arizona, United States

ET Nursing Services; 🇺🇸 Jacksonville, Florida, United States

Image Specialties; 🇺🇸 Saint Joseph, Missouri, United States

ID MED Inc.; 🇺🇸 Columbus, Ohio, United States