Comparison Study of 3 Ostomy Products
A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products
1 other identifier
interventional
26
1 country
4
Brief Summary
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 7, 2022
December 1, 2022
2 months
September 12, 2012
December 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Leakage & Wear Time
Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.
10 days
Secondary Outcomes (1)
Number of adverse events
10 days
Study Arms (6)
Ostomy 1
OTHER3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
Ostomy 2
OTHER3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1
Ostomy 3
OTHER3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product
Ostomy 4
OTHER3 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
OTHER3 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
OTHER3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1
Interventions
Wearing each of the devices for 10 days each
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ConvaTec Inc.lead
Study Sites (4)
Independent Nurse Consultants
Tucson, Arizona, 85742, United States
ET Nursing Services
Jacksonville, Florida, 32257, United States
Image Specialties
Saint Joseph, Missouri, 64506, United States
ID MED Inc.
Columbus, Ohio, 43222, United States
Study Officials
- STUDY DIRECTOR
Kim Peters
ConvaTec Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 25, 2012
Study Start
September 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
December 7, 2022
Record last verified: 2022-12