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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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12 December 2020 |
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Main ID: |
NCT03508674 |
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Date of registration:
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16/04/2018 |
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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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Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
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Scientific title:
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Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System |
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Date of first enrolment:
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April 23, 2018 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03508674 |
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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: Other. 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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Chile
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Contacts
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Name:
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Dana Portenier, 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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Duke Regional Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- at least 18 years of age
- scheduled to undergo bariatric procedure
Exclusion Criteria:
- Am Soc Anesthesiology score of III or IV
- significant comorbidities
- subjects contraindicated for use of magnetic system
- clinical history of impaired coagulation
- hepatic abnormality or anatomical abnormality
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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Bariatric Surgery Candidate
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Intervention(s)
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Device: Levita Magnetic Surgical System
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Primary Outcome(s)
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Incidence of device related adverse events (safety)
[Time Frame: Through 30 days post bariatric procedure]
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Number and types of tools required to mobilize the liver during procedure
[Time Frame: During planned bariatric procedure. (approximately 2 hours on a single day.)]
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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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