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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00593021 |
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Date of registration:
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28/12/2007 |
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Primary sponsor: |
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Public title:
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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
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Scientific title:
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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00593021 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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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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Jaya R Agrawal, MD, MPH |
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Address:
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Telephone:
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617-525-8763 |
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Email:
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jagrawal@partners.org |
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Affiliation:
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Name:
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Jaya R Agrawal, MD, MPH |
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Address:
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Telephone:
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617-525-8763 |
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Email:
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jagrawal@partners.org |
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Affiliation:
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Name:
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John R Saltzman, 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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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative
EGD+/-colonoscopy
Exclusion Criteria:
- Under the age of 18
- Unable to give consent
- IV Contrast Allergy (excluded from CT)
- Renal insufficiency (excluded from CT)
- Unable to swallow (excluded from capsule)
- Small bowel obstruction or stricturing disease (excluded from capsule)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obscure Gastrointestinal Bleeding
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Primary Outcome(s)
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Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding
[Time Frame: Continuous]
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Secondary Outcome(s)
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Hospital course, clinical improvement
[Time Frame: 120 days from enrollment]
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Secondary ID(s)
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SALTZMAN: 2007P-000991
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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