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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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16 December 2017 |
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Main ID: |
NCT03111758 |
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Date of registration:
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07/04/2017 |
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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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Flow Augmentation Study in Postthrombotic Patients
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Scientific title:
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Flow Augmentation With Geko Device in Patients With Postthrombotic Syndrome a Prospective Randomised Cross-Over Trial |
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Date of first enrolment:
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April 3, 2017 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03111758 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. 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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Netherlands
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Contacts
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Name:
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Suat Doganci, MD |
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Address:
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Telephone:
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+31654637963 |
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Email:
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suat.doganci@mumc.nl |
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Affiliation:
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Name:
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Cees Wittens, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastricht University Hospital |
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Name:
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Suat Doganci, Md |
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Address:
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Telephone:
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+31654637963 |
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Email:
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suat.doganci@mumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Post-thrombotic obstruction that requires percutaneous intervention through stenting,
minimally 18 years of age
Exclusion Criteria:
- Peripheral arterial disease, comorbidities leading to impaired muscle function of
either lower limb, co-morbidities affecting the circulatory system, history of deep
venous surgery in either lower limb or groin, allergies to the plasters, pregnancy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Postthrombotic Syndrome
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Intervention(s)
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Device: Flow augmentation
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Primary Outcome(s)
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Time Averaged Maximum Flow Velocity
[Time Frame: Five times one minute measurement]
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Secondary ID(s)
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NL59864.068.16
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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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