Effectiveness of Artificial Intelligence - Assisted Colonoscopy in Colorectal Neoplasms (ArtInCol)

June 17, 2024 updated by: State Scientific Centre of Coloproctology, Russian Federation

Artificial Intelligence - Assisted Colonoscopy in Diagnosis of Colorectal Neoplasms: Russian Multicenter Randomised Open - Label Trial

The primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors.

Researchers will compare Adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary outcome is adenoma detection rate per patient.

The secondary outcomes will be measured:

  • Polyps detection rate (all type of lesions) per patient;
  • Number of adenomas per patient;
  • Number of polyps per patient;

Study Type

Interventional

Enrollment (Estimated)

1000

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

  • Name: Dmitriy Shakhmatov
  • Phone Number: +79035651441
  • Email: mma02@yandex.ru

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Airat Mingazov
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergey Achkasov
        • Sub-Investigator:
          • Dmitriy Shakhmatov
        • Sub-Investigator:
          • Alexey Likutov
        • Sub-Investigator:
          • Airat Mingazov
        • Sub-Investigator:
          • Ilya Nazarov

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Screening coloscopy is needed

Exclusion Criteria:

  • Indications for colonoscopy
  • Previously detected colorectal neoplasms
  • Previously performed colorectal surgery
  • Colorectal cancer
  • Inflammatory bowel disease

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artificial intelligence - assisted colonoscopy

The decision making system based on artificial intelligence. Real - time artificial intelligence - assisted colonoscopy will be performed in this group.

Detection of polyps is based on real time fixing a frame on the screen.
Device: The system based on real - time artificial intelligence - assisted for colonoscopy
Russian medical decision support system based on artificial intelligence "ArtInCol"
Active Comparator: Conventional colonoscopy
Conventional colonoscopy will be performed in this group
Device: The system based on real - time artificial intelligence - assisted for colonoscopy
Russian medical decision support system based on artificial intelligence "ArtInCol"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: during the procedure
In each group, the percentage of patients with at least one histologically proven adenoma or carcinoma
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyps detection rate
Time Frame: during the procedure
In each group, the number of patients with all type of neoplasms (polyps) was detected as a percentage of the total number of patients.
during the procedure
Number of polyps
Time Frame: during the procedure
In each group, the number of detected all type of polyps
during the procedure
Number of adenomas
Time Frame: during the procedure
In each group, the number of detected adenomas
during the procedure

Collaborators and Investigators

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

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Investigators

  • Principal Investigator: Sergey Achkasov, State scientific centre of coloproctology, Moscow

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7-24

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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