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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 October 2017 |
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Main ID: |
NCT02230540 |
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Date of registration:
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28/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intermittent Catheterization in Spinal Cord Injured Men
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Scientific title:
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Date of first enrolment:
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September 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02230540 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Per Bagi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Has given written informed consent
- Is at least 18 years of age and has full legal capacity
- Is a male
- Has an Spinal Cord Injury diagnosis
Exclusion Criteria:
- Participating in other interventional clinical investigations or have previously
participated in this investigation
- Known hypersensitivity toward any of the test products
- Serious abdominal scars
- Symptoms of urinary tract infections
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injuries
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Intervention(s)
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Device: Product B SelfCath and urine bag, Conveen Contour
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Device: SelfCath (comparator)
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Device: Product A SelfCath and urine bag, Conveen Security+
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Primary Outcome(s)
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Residual Volume Less Than 100ml
[Time Frame: 2-4 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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