The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

January 3, 2026 updated by: Limian Er

The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer: A Multicenter Randomized Controlled Study

The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

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: Li mian Er, Doctor
  • Phone Number: 13513379068
  • Email: Hbsyelm@163.com

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Fourth Hospital of Hebei Medical University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea

Description

Inclusion Criteria:

1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.

Exclusion Criteria:

  1. Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
  2. Those with intestinal obstruction or malignant tumors
  3. Patients with colorectal lesions that need to be treated in stages.
  4. Other contraindications for colonoscopy 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI group
Procedure: AI group
Full AI assistance was used throughout the standard colonoscopy procedure.
Series group
Procedure: Serial group
After normal withdrawal of the colonoscope to the splenic flexure during standard colonoscopy, full AI assistance was initiated. The colonoscope was re-entered to the ileocecal region for observation. Any missed lesions were recorded.
Standard group
Procedure: Standard colonoscopy group
The standard colonoscopy procedure was performed as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: Day 1
The proportion of patients who have at least one adenoma detected during colonoscopy examination
Day 1
Average adenoma detection rate
Time Frame: Day 1
The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.
Day 1

Collaborators and Investigators

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

Sponsor

Limian Er

Investigators

  • Study Director: Li mian Er, Hebei Medical University Fourth Hospital

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 (Estimated)

February 26, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KS177

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.

Clinical Trials on Abdominal Pain

Clinical Trials on AI group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe