The Implementation of Computer-aided Detection in Training Improves the Quality of Future Colonoscopies

January 15, 2025 updated by: Zofia Orzeszko, Jagiellonian University

The Implementation of Computer-aided Detection in an Initial Endoscopy Training Improves the Quality Measures of Trainees' Future Colonoscopies

Computer-aided detection (CADe) based on artificial intelligence (AI) may improve colonoscopy quality. An increasing number of young endoscopists are trained in an AI environment. However its impact on trainees' future outcomes remains unclear. The study aimed to evaluate the quality indicators of endoscopists trained in an AI environment compared to those trained conventionally.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Computer-aided detection (CADe) based on artificial intelligence (AI) may improve colonoscopy quality. An increasing number of young endoscopists are trained in an AI environment. However its impact on trainees' future outcomes remains unclear. The study aimed to evaluate the quality indicators of endoscopists trained in an AI environment compared to those trained conventionally. A study included 6,000 adult patients who underwent a colonoscopy for various reasons. The study retrospectively evaluated the first 1,000 procedures performed by six endoscopists after completing training relying entirely on endoscopists' detection skills without AI enhancement. Three of those young endoscopists were trained with CADe, and three without additional assistance. Quality indicators were assessed in both groups. The morphology of detected polyps was evaluated to determine the influence of AI-enhanced training on laterally spreading tumors (LST) detection rate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Contacts and Locations

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

Study Locations

  • Poland
      • Kraków, Poland, 31007
        • Jagiellonian University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study included 6,000 adult patients who underwent a colonoscopy for various reasons in a single high-volume endoscopy clinic in Krakow.

Description

Inclusion Criteria:

  • adult participants who underwent a colonoscopy for various reasons performed by specific endoscopists that were assessed in terms of quality indicators

Exclusion Criteria:

  • a history of bowel resection
  • confirmed inflammatory bowel disease
  • suspicion of polyps or cancer in other imaging tests
  • suspicion of familial adenomatous polyposis

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group A
Colonoscopies performed by endoscopists trained in AI-enhanced environment. The quality indicators are measured after completing training without AI enhancement.
Other: AI-enhanced endoscopy training
Endoscopists trained in AI-enhanced environment. Their quality indicators are measured after completing training, without additional AI enhancement.
Group B
Colonoscopies performed by endoscopists trained conventionally. The quality indicators are measured after completing training without AI enhancement.
Other: Conventional endoscopy training
Endoscopists trained conventionally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
withdrawal time
Time Frame: During the colonoscopy examination
The time from the cecal intubation to the end of the examination
During the colonoscopy examination
Cecal intubation rate (CIR)
Time Frame: During the colonoscopy examination
The percentage of colonoscopies with successful cecal intubations
During the colonoscopy examination
Adenoma Detection Rate (ADR)
Time Frame: During the colonoscopy examination
The percentage of colonoscopies when the adenoma was found
During the colonoscopy examination
Advanced adenoma detection rate (AADR)
Time Frame: During the colonoscopy examination
The percentage of colonoscopies when the advanced adenoma (>10mm) was found
During the colonoscopy examination
Adenoma per colonoscopy score (APC)
Time Frame: During the colonoscopy examination
The average number of adenomas detected in a single colonoscopy
During the colonoscopy examination
Serrated polyp detection rate (SDR)
Time Frame: During the colonoscopy examination
The percentage of colonoscopies when the serrated polyp was found
During the colonoscopy examination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laterally spreading tumor detection rate
Time Frame: During the colonoscopy examination
The percentage of colonoscopies when the laterally spreading tumor lesion was found
During the colonoscopy examination

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jagiellonian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zofia Orzeszko, MD, Jagiellonian University
  • Study Chair: Miroslaw Szura, PhD, Prof., Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024.000.367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Drug Interventions

Conditions

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Dietary Supplements

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