CDSS-assisted UGI Endoscopy vs. Routine Screening Endoscopy

July 11, 2022 updated by: Chang Seok Bang, Chuncheon Sacred Heart Hospital

Clinical Benefit in the CDSS-assisted Screening Upper Gastrointestinal Endoscopy vs. Routine Screening Endoscopy

This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Artificial intelligence has been adopted in the field of gastrointestinal endoscopy. Investigators previously established deep-learning models to predict the histology and invasion depth of gastric lesions using endoscopic stillcut images. However, clinical benefit of this model has not been evaluated. This study aimed to find the CDSS-assisted upper GI endoscopy has clinical benefit compared to conventional routine screening upper GI endoscopy. Investigators will conduct a pilot randomized controlled study. Consecutive patients who visited Chuncheon Sacred Heart hospital will be allocated either to CDSS-assisted upper GI endoscopy or conventional routine screening upper GI endoscopy. The lesion detection rate will be compared between both groups. Expert endoscopists will conduct this randomized study.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who visited for routine screening upper gastrointestinal endoscopy

Exclusion Criteria:

  • Participants who refuse to participate in this study
  • Participants who showed paradoxical reaction prohibiting routine examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CDSS-assisted screening endoscopy
Participants will be tested for CDSS-assisted screening upper gastrointestinal endoscopy
Other: CDSS-assisted upper GI endoscopy
Expert endoscopists perform screening upper gastrointestinal endoscopy while looking at the monitor (CDSS system: automatic detection or lesion classification function) and listening to the sound of the monitor next to the original endoscopy monitor system.
PLACEBO_COMPARATOR: Conventional routine screening endoscopy
Participants will be tested for Conventional routine screening upper gastrointestinal endoscopy
Other: no intervention
Expert endoscopists perform routine screening upper gastrointestinal endoscopy without CDSS's help.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric lesion detection rate
Time Frame: Baseline (gold standard; ground truth is expert endoscopists' lesion detection)
Gastric lesions (low or high grade dysplasia, early gastric cancer, or advanced gastric cancer) detection rate
Baseline (gold standard; ground truth is expert endoscopists' lesion detection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion classification accuracy
Time Frame: Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)
Whether CDSS correctly diagnosed detected lesions or not
Baseline (gold standard; ground truth is histologic diagnosis of detected lesions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2022

Primary Completion (ANTICIPATED)

August 6, 2022

Study Completion (ANTICIPATED)

December 6, 2022

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (ACTUAL)

July 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI RCT1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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