Comparison Study of 3 Ostomy Products

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

Detailed Description
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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.

Official Title
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A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products

Conditions
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Ostomy

Intervention / Treatment
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* Device: Ostomy accessory


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ostomy 1<br>3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2 | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|
| Other: Ostomy 2<br>3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1 | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|
| Other: Ostomy 3<br>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|
| Other: Ostomy 4<br>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|
| Other: Ostomy 5<br>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2 | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|
| Other: Ostomy 6<br>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1 | Device: Ostomy accessory<br>* Wearing each of the devices for 10 days each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage & Wear Time | Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Evaluation and comparison of the safety of three ostomy accessory products | 10 days |