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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00294450 |
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Date of registration:
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20/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Feasibility Study of a New Fistula Pouching System
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Scientific title:
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Pouching of Fistula - a Non-comparative, Multi-center Investigation |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00294450 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Thais Benjamin N. Christensen, M.Sc. (BME) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Coloplast A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years or older
- Capable of giving informed consent
- Have to be hospitalized
- Have a fistula with the opening on the skin in the abdominal area
Exclusion Criteria:
- Pregnant and/or breast-feeding
- Receiving radiation- or chemotherapy during the investigation period
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cutaneous Fistula
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Intervention(s)
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Device: Fistula Pouching System
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Primary Outcome(s)
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Nurse's preference to use the test product in the future
[Time Frame: Up to 18 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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