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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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18 January 2016 |
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Main ID: |
NCT01384240 |
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Date of registration:
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27/06/2011 |
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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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Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
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Scientific title:
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Evaluation of Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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183 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01384240 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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Phase:
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Phase 0
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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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Sharmila Anandasabapathy, 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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Icahn School of Medicine at Mount Sinai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- surveillance of polyps or disease of the colon
- screening colonoscopy
- anoscopy for suspected or known anal dysplasia or neoplasia
Exclusion Criteria:
- unfit for standard colonoscopy or anoscopy
- unable to provide informed consent
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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Colon Polyps
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Colonic Dysplasia
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Anal Dysplasia
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Intervention(s)
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Drug: Proflavine Hemisulfate
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Primary Outcome(s)
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to determine whether tissue in nepoplastic or non-neoplastic
[Time Frame: 1 day]
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Secondary ID(s)
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GCO# 09-1040
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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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