Recruiting

AI

Sponsor:

University of Southern California

Code:

NCT05423964

Conditions

Adenoma

Adenoma Colon

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

AI use in Endoscopy Room

Non-AI use Standard of Care endoscopy room

Study Details

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.

Conditions

Adenoma

Adenoma Colon

Colorectal Cancer

Study ID

NCT05423964

Start date

Jan 1, 2023

Status verified date

Mar, 2023

Completion date

Sep, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Artificial Intelligence Endoscopy Room

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

active comparator: 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).

Interventions

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.

Primary outcome measure

  • Average adenoma detection rate [ Time Frame: Throughout study, an average of 2 years ]

Central Contacts and Locations

Central contacts

Jessica Serna, BS

323-409-6939Jessica.Serna@med.usce.edu

Alex Rodriguez, BS

323-409-6939Alex.Rodriguez@med.usc.edu

Locations

LAC+USC Medical Center

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University of Southern California

Last update posted

Mar 6, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-03-06.