Comparison Study of 3 Ostomy Products

Not Applicable

Completed

• Conditions: Ostomy
• Interventions: Device: Ostomy accessory

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ostomy 1	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
Ostomy 3	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product
Ostomy 2	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1
Ostomy 4	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product
Ostomy 5	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2
Ostomy 6	Ostomy accessory	3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1

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)

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

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

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

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