A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
NCT ID: NCT02064231
Last Updated: 2020-09-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2012-06-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Influence of Baseplate Adhesive on the Degree of Leakage
NCT01995357
Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
NCT02694757
Evaluation of the Performance of a New Adhesive Strip
NCT03257787
A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put
NCT02610907
Evaluation of the Effect of Output on New Adhesives
NCT03257774
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Coloplast Test A, Coloplast Test B, Own product
The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days
Coloplast Test A
Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C , Coloplast Test D, Own product
The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days
Own product
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C
Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D
Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Coloplast Test A
Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
Coloplast Test B
Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
Own product
Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
Coloplast Test C
Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
Coloplast Test D
Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Was at least 18 years of age
3. Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
4. Had an ileostomy with a diameter between 15-45 mm
5. Have had an ileostomy for at least 3 months
6. Currently used a 2-piece flat appliance
Exclusion Criteria
2. Currently received or had within the past 2 months received radio- and/or chemotherapy.
3. Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
4. Was pregnant or breast feeding
5. Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
6. Had a baseplate wear time of more than three days
7. Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coloplast A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birte p Jakobsen, MD
Role: PRINCIPAL_INVESTIGATOR
Medical director
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP222
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.