Ostomy
Conditions
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.
Interventions
DEVICEOstomy accessory
Wearing each of the devices for 10 days each
Sponsors
ConvaTec Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage & Wear Time | 10 days | Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 10 days | Evaluation and comparison of the safety of three ostomy accessory products |
Countries
United States
Outcome results
None listed