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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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27 March 2023 |
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Main ID: |
NCT01828190 |
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Date of registration:
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08/04/2013 |
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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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The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
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Scientific title:
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Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01828190 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Haim Shirin, 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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Assaf Harofe Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
patients aged 18 and above that suffer from Crohn's disease one or more perianal draining
fistulas for at least 3 months currently receiving a TNFalpha blocker for at least 3 months
(without improvement of the perianal disease)
Exclusion Criteria:
Pregnancy or plans to conceive during the next year Inability (such as previous adverse
effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with
TNF alpha blockers treatment.
Any past or current malignancy Treatment with HBOT in the last year Claustrophobia Middle
ear problems Inability to equalize pressure in the middle ear Medical status that precludes
treatment with HBOT such as chest X-ray abnormality, epilepsy, severe congestive heart
failure, uncontrolled diabetes or uncontrolled hypertension Any perianal surgery in the
last 6 months Any change in Crohn's disease medications in the last 3 months
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Perianal Fistulas
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Crohn's Disease
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Intervention(s)
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Other: Hyperbaric oxygen
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Primary Outcome(s)
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Reduction of fistulas number
[Time Frame: 0, 32 weeks]
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Secondary Outcome(s)
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Reduction of perianal symptoms
[Time Frame: 0, 4, 8, 14, 20, 32]
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Secondary ID(s)
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HBOT- fistulas non-naive
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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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