Overview

This trial is active, not recruiting.

Condition ostomy
Treatment ostomy accessory
Sponsor ConvaTec Inc.
Start date September 2012
End date November 2012
Trial size 26 participants
Trial identifier NCT01691729, A739

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
ostomy accessory
Wearing each of the devices for 10 days each
(Other)
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 accessory
Wearing each of the devices for 10 days each
(Other)
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 accessory
Wearing each of the devices for 10 days each
(Other)
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 accessory
Wearing each of the devices for 10 days each
(Other)
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 accessory
Wearing each of the devices for 10 days each
(Other)
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1
ostomy accessory
Wearing each of the devices for 10 days each

Primary Outcomes

Measure
Leakage & Wear Time
time frame: 10 days

Secondary Outcomes

Measure
Number of adverse events
time frame: 10 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by ConvaTec Inc..