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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02567240 |
Date of registration:
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01/10/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Carbon Monoxide-Saturated Medium for Islet Isolation
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Scientific title:
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A Novel Approach to Harvest Islets for Autologous Islet Transplantation |
Date of first enrolment:
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January 2015 |
Target sample size:
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16 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02567240 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 1/Phase 2
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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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Hongjun Wang, Ph.D |
Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of South Carolina |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Chronic pancreatitis patient selected for total pancreatectomy and islet
autotransplantation.
2. Age between 18-69.
Exclusion Criteria:
1. Had prior pancreatic surgeries.
Note: The study was initially designed only to enroll diabetes free patients. To increase
enrollment, we extended the inclusion criteria by allowing patients who are pre-diabetic to
participate the study. This revision was approved by the MUSC IRB on 11/10/2015.
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Pancreatitis
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Intervention(s)
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Other: Carbon monoxide-bubbled mediums
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Primary Outcome(s)
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Area under the curve during mixed meal tolerance test
[Time Frame: 6 months]
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Secondary ID(s)
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Pro00040035
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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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