Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2012-09-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Ostomy 1
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
Ostomy 2
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
Ostomy 3
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
Ostomy 4
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
Ostomy 5
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
Ostomy 6
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
Interventions
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Ostomy accessory
Wearing each of the devices for 10 days each
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Peters
Role: STUDY_DIRECTOR
ConvaTec Inc.
Locations
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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
Countries
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Other Identifiers
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A739
Identifier Type: -
Identifier Source: org_study_id
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