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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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19 February 2015 |
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Main ID: |
NCT02352233 |
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Date of registration:
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05/08/2014 |
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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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Retroview Colonoscope for the Evaluation of Colon Mucosa Study
REVCOR |
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Scientific title:
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Pentax Retroview Colonoscope for the Evaluation of Colon Mucosa in Forward and Retro Viewing: a Safety and Feasibility Pilot Study |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02352233 |
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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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Phase:
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N/A
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Countries of recruitment
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Ecuador
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Contacts
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Name:
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Carlos Robles-Medranda, 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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Instituto Ecuatoriano de Enfermedades Digestivas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or
for diagnostic workup including anemia, abdominal pain, constipation, abnormal
imaging; and if they were able to understand and provide written consent for the
procedure.
Exclusion Criteria:
- age <18; pregnancy, included history of colon resection, known inflammatory bowel
disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of
chronic stricture potentially precluding complete colonoscopy, presence of
diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another
clinical investigation.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colonic Diseases
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Intervention(s)
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Procedure: RETROVIEW colonoscope
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Primary Outcome(s)
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Feasibility
[Time Frame: 3 months]
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Safety
[Time Frame: 3 months]
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Secondary Outcome(s)
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Withdrawal colonoscopy phase
[Time Frame: 3 months]
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Total procedure time
[Time Frame: 3 months]
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Secondary ID(s)
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IECED 2014-01
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IECED 01-14-2014
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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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