Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia
NCT ID: NCT01384240
Last Updated: 2016-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
183 participants
INTERVENTIONAL
2010-04-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Proflavine Hemisulfate
Proflavine Hemisulfate
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
Interventions
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Proflavine Hemisulfate
3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* screening colonoscopy
* anoscopy for suspected or known anal dysplasia or neoplasia
Exclusion Criteria
* unable to provide informed consent
18 Years
ALL
No
Sponsors
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Anandasabapathy, Sharmila, M.D.
INDIV
Responsible Party
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Principal Investigators
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Sharmila Anandasabapathy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Medical Center
New York, New York, United States
Countries
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References
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Chang SS, Shukla R, Polydorides AD, Vila PM, Lee M, Han H, Kedia P, Lewis J, Gonzalez S, Kim MK, Harpaz N, Godbold J, Richards-Kortum R, Anandasabapathy S. High resolution microendoscopy for classification of colorectal polyps. Endoscopy. 2013 Jul;45(7):553-9. doi: 10.1055/s-0032-1326502. Epub 2013 Jun 18.
Other Identifiers
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GCO# 09-1040
Identifier Type: -
Identifier Source: org_study_id
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