Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
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ClinicalTrials.gov Identifier: NCT01994902 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
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Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
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Tracking Information | ||||
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First Submitted Date ICMJE | October 18, 2013 | |||
First Posted Date ICMJE | November 26, 2013 | |||
Results First Submitted Date ICMJE | November 3, 2015 | |||
Results First Posted Date ICMJE | January 12, 2016 | |||
Last Update Posted Date | January 12, 2016 | |||
Study Start Date ICMJE | November 2013 | |||
Actual Primary Completion Date | June 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Degree of Leakage [ Time Frame: 28 +/- 3 days ] The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
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Original Primary Outcome Measures ICMJE |
Degree of Leakage [ Time Frame: 28 +/- 3 days ] The degree of leakage is measured using a 33-point scale developed by Coloplast A/S.
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy | |||
Official Title ICMJE | Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy. | |||
Brief Summary | The aim of the investigation was to investigate the performance and safety of a new ostomy product. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Stoma Ileostomy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
129 | |||
Original Estimated Enrollment ICMJE |
223 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | June 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark, France, Germany, Norway, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01994902 | |||
Other Study ID Numbers ICMJE | CP232 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Coloplast A/S | |||
Study Sponsor ICMJE | Coloplast A/S | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Coloplast A/S | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |