Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study (NBI)
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ClinicalTrials.gov Identifier: NCT01310699 |
Recruitment Status
:
Completed
First Posted
: March 8, 2011
Results First Posted
: April 6, 2017
Last Update Posted
: December 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Neoplasms Colonic Polyps Colorectal Cancer | Device: Olympus Colonoscope CFHQ190AL | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 281 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Diagnostic |
Official Title: | Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | August 2016 |
Arm | Intervention/treatment |
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Experimental: High Definition NBI Colonoscopy
Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
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Device: Olympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.
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Placebo Comparator: High Definition White Light Colonoscopy
Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.
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Device: Olympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.
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- Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm [ Time Frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology) ]Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
- Percentage of Missed Lesions on Index Colonoscopy. [ Time Frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology) ]Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
- Percentage of Nonpolypoid (Flat) Missed Lesions [ Time Frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology) ]Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adult patients referred for routine colonoscopy are eligible
Exclusion Criteria:
- Known Inflammatory bowel disease
- Referred for endoscopic evaluation and removal of colorectal lesion
- Personal or family history of polyposis or non-polyposis syndrome
- Presentation for emergency endoscopy
- Inability to remove polyp due to coagulopathy or thrombocytopenia
- Inability to provide informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310699
United States, California | |
Veterans Affairs Palo Alto | |
Palo Alto, California, United States, 94304 | |
Veterans Affairs San Francisco | |
San Francisco, California, United States, 94121 | |
United States, Missouri | |
Veterans Affairs Kansas City | |
Kansas City, Missouri, United States, 64128 |
Principal Investigator: | Tonya Kaltenbach, MD MS | San Francisco Veterans Affairs Medical Center |
Additional Information:
Publications:
Responsible Party: | Roy Soetikno, Co-Principal Investigator, VA Palo Alto Health Care System |
ClinicalTrials.gov Identifier: | NCT01310699 History of Changes |
Other Study ID Numbers: |
FIND FLAT PA19624 |
First Posted: | March 8, 2011 Key Record Dates |
Results First Posted: | April 6, 2017 |
Last Update Posted: | December 6, 2017 |
Last Verified: | October 2017 |
Keywords provided by Roy Soetikno, VA Palo Alto Health Care System:
Colonoscopy Diagnostic imaging Colorectal Neoplasm Tandem Colonoscopy Flat Polyp |
Nonpolypoid Flat and Depressed Lesions Primary Prevention Endoscopy |
Additional relevant MeSH terms:
Colorectal Neoplasms Polyps Colonic Polyps Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pathological Conditions, Anatomical Intestinal Polyps |