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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UNKNOWN
NA
25 participants
INTERVENTIONAL
2023-01-01
2025-09-30
Brief Summary
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Detailed Description
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Fellows will undergo educational session prior to the start of study, describing commonly used metrics for assessing quality of colonoscopy and how to use the artificial intelligence software. Gastroenterology fellows will be consented for the study prior to initiation. The fellows will be randomized on a daily basis to perform colonoscopies in a room. Outcomes will measure the effects of AI in fellows
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Artificial Intelligence Endoscopy Room
The fellows will be randomized on a daily basis to perform colonoscopies in a room with AI (intervention)
AI use in Endoscopy Room
The use of AI versus no AI in comparing the detection of adenomas during Endoscopy procedures.
Non-Artificial Intelligence Endoscopy Room
The fellows will be randomized on a daily basis to perform colonoscopies in a non-AI endoscopy room (standard of care).
Non-AI use Standard of Care endoscopy room
Non-AI use in comparing the detection of adenomas during Endoscopy procedures.
Interventions
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AI use in Endoscopy Room
The use of AI versus no AI in comparing the detection of adenomas during Endoscopy procedures.
Non-AI use Standard of Care endoscopy room
Non-AI use in comparing the detection of adenomas during Endoscopy procedures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Procedures performed in the intensive care unit or the operating room will not be counted toward the study metrics as the AI system will only be available in the endoscopy unit.
* If procedures are performed only by faculty, in which the fellow is not the primary operator, they will not be used for study metrics.
ALL
Yes
Sponsors
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University of Southern California
OTHER
Responsible Party
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James Buxbaum
Associate Professor
Principal Investigators
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James L Buxbaum, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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LAC+USC Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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James Buxbaum, MD
Role: primary
References
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Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1.
Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
Rex DK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Levin TR, Lieberman D, Robertson DJ. Colorectal Cancer Screening: Recommendations for Physicians and Patients from the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017 Jul;112(7):1016-1030. doi: 10.1038/ajg.2017.174. Epub 2017 Jun 6.
Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086.
Abadir AP, Ali MF, Karnes W, Samarasena JB. Artificial Intelligence in Gastrointestinal Endoscopy. Clin Endosc. 2020 Mar;53(2):132-141. doi: 10.5946/ce.2020.038. Epub 2020 Mar 30.
Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1.
Calderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.
Kaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667.
Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.
Other Identifiers
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HS-21-00094
Identifier Type: -
Identifier Source: org_study_id
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