NCT05423964

Brief Summary

Adenoma detection rate (ADR) is a validated quality metric for colonoscopy with higher ADR correlated with improved colorectal cancer outcomes. Artificial intelligence (AI) can automatically detect polyps on the video monitor which may allow endoscopists in training to improve their ADR. Objective and Purpose of the study: Measure the effect of AI in a prospective, randomized manner to determine its impact on ADR of Gastroenterology trainees.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

April 26, 2022

Last Update Submit

March 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average adenoma detection rate

    Adenoma detection rate with and without AI

    Throughout study, an average of 2 years

Secondary Outcomes (1)

  • Average of polyps detection rate

    Through out study, an average of 2 years

Study Arms (2)

Artificial Intelligence Endoscopy Room

ACTIVE COMPARATOR

The fellows will be randomized on a daily basis to perform colonoscopies in a room with AI (intervention)

Diagnostic Test: AI use in Endoscopy Room

Non-Artificial Intelligence Endoscopy Room

ACTIVE COMPARATOR

The fellows will be randomized on a daily basis to perform colonoscopies in a non-AI endoscopy room (standard of care).

Other: Non-AI use Standard of Care endoscopy room

Interventions

The use of AI versus no AI in comparing the detection of adenomas during Endoscopy procedures.

Artificial Intelligence Endoscopy Room

Non-AI use in comparing the detection of adenomas during Endoscopy procedures.

Non-Artificial Intelligence Endoscopy Room

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Gastroenterology fellows at USC performing Endoscopies will be included in the study.

You may not qualify if:

  • If fellows refuse informed consent they will be excluded.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (12)

  • 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.

    PMID: 28248415BACKGROUND
  • 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.

    PMID: 8247072BACKGROUND
  • 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.

    PMID: 22356322BACKGROUND
  • 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.

    PMID: 28555630BACKGROUND
  • 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.

    PMID: 24693890BACKGROUND
  • 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.

    PMID: 32252506BACKGROUND
  • 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.

    PMID: 29928897BACKGROUND
  • 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.

    PMID: 32371116BACKGROUND
  • 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.

    PMID: 20883845BACKGROUND
  • 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.

    PMID: 20463339BACKGROUND
  • 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.

    PMID: 30986402BACKGROUND
  • Chang PW, Nguyen DD, Kong N, Wang D, Wang S, Ong J, Amini MM, Sharma N, Bui A, Bakr O, Bruce D, Lee H, Dodge JL, Sahakian AB, Buxbaum JL. Impact of artificial intelligence-assisted colonoscopy on gastroenterology fellow performance: a pragmatic randomized controlled trial. Gastrointest Endosc. 2025 Sep 27:S0016-5107(25)02063-2. doi: 10.1016/j.gie.2025.09.045. Online ahead of print.

MeSH Terms

Conditions

AdenomaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • James L Buxbaum, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 26, 2022

First Posted

June 21, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations