Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods
NCT ID: NCT02668198
Last Updated: 2019-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2016-01-31
2018-10-31
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
DIAGNOSTIC
NONE
Study Groups
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Endoscopic scar assessment
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Olympus CF190 Colonoscope High definition white light
Standard endoscopic imaging technique
Olympus CF190 Colonoscope White light with near focus
Near focus mode is used to closely examine the area of prior EMR site.
Olympus CF190 Colonoscope Narrow band imaging
Narrow band imaging is utilized to examine the area of prior EMR.
Olympus CF190 Colonoscope Narrow band imaging with near focus
NBI with near focus to help closely examine the area of prior EMR site.
Biopsy
Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment
Interventions
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Olympus CF190 Colonoscope High definition white light
Standard endoscopic imaging technique
Olympus CF190 Colonoscope White light with near focus
Near focus mode is used to closely examine the area of prior EMR site.
Olympus CF190 Colonoscope Narrow band imaging
Narrow band imaging is utilized to examine the area of prior EMR.
Olympus CF190 Colonoscope Narrow band imaging with near focus
NBI with near focus to help closely examine the area of prior EMR site.
Biopsy
Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Breast feeding
18 Years
ALL
Yes
Sponsors
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Olympus America, Inc.
INDUSTRY
Michael Wallace
OTHER
Responsible Party
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Michael Wallace
Consultant, Professor of Medicine
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Countries
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References
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Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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15-007241
Identifier Type: -
Identifier Source: org_study_id
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