Impact of AI on Trainee ADR

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05423964
Collaborator
(none)
25
2
39

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: AI use in Endoscopy Room
  • Other: Non-AI use Standard of Care endoscopy room
N/A

Detailed Description

Our objective is to determine the impact of AI on the adenoma detection rate of Gastroenterology trainees. The secondary aim of this quality improvement study is to determine the impact of AI based endoscopy on the rate of recording of quality improvement metrics versus historical performance in our program.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Artificial Intelligence on Trainee Adenoma Detection Rate
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Artificial Intelligence Endoscopy Room

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

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).

Other: Non-AI use Standard of Care endoscopy room
Non-AI use in comparing the detection of adenomas during Endoscopy procedures.

Outcome Measures

Primary Outcome Measures

  1. Average adenoma detection rate [Throughout study, an average of 2 years]

    Adenoma detection rate with and without AI

Secondary Outcome Measures

  1. Average of polyps detection rate [Through out study, an average of 2 years]

    Polyp detection rate with and without AI

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southern California

Investigators

  • Principal Investigator: James L Buxbaum, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
James Buxbaum, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT05423964
Other Study ID Numbers:
  • HS-21-00094
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022