Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN) (AI-COLOSCREEN)

February 8, 2026 updated by: Ding Ke-Feng, Zhejiang University

A Multi-center, Randomized, Controlled Clinical Study on the Efficacy of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions.

This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed lesions. This trial aims to determine if AI can enhance screening quality and diagnostic accuracy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer (CRC) screening is crucial for early detection and reducing mortality, yet current colonoscopy techniques face challenges such as variable adenoma detection rates (ADR) and the risk of missed diagnoses for subtle lesions. This study is a prospective, multi-center, parallel-group, randomized controlled trial aiming to validate the clinical value of an AI-assisted diagnostic system in improving screening quality. A total of 3342 participants will be randomized in a 1:1 ratio to undergo either AI-assisted colonoscopy (Experimental Group) or conventional high-definition colonoscopy (Control Group). The primary objective is to compare the ADR between the two groups. Secondary objectives include assessing the detection rate of advanced or specific types of polyps, the mean number of adenomas per procedure, and the impact of the AI system on both patient and physician satisfaction. The study will provide high-quality evidence for the standardized application of AI technology in CRC screening, with the ultimate goal of reducing the incidence and mortality of colorectal cancer.

Study Type

Interventional

Enrollment (Estimated)

3342

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

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age between 18 and 75 years, inclusive.
  2. Scheduled for a screening, diagnostic, or surveillance colonoscopy.
  3. Able to understand the study protocol and provide written informed consent.

Exclusion Criteria:

  1. Known contraindications to colonoscopy or biopsy.
  2. Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery.
  3. Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP).
  4. Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon.
  5. Women who are pregnant, planning to become pregnant, or are breastfeeding.
  6. Participation in another interventional clinical trial within the 30 days prior to enrollment.
  7. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: AI-Assisted Colonoscopy
Participants will undergo a high-definition colonoscopy procedure where a real-time artificial intelligence system analyzes the video feed to assist the endoscopist in identifying and highlighting suspicious lesions.
Device: AI-Assisted Colonoscopy
High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
No Intervention: Control: Conventional Colonoscopy
Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence system. The AI software will not be active during these procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate (ADR)
Time Frame: From the day of the procedure up to 14 days post-procedure.
The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports.
From the day of the procedure up to 14 days post-procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Adenomas Per Colonoscopy (APC)
Time Frame: From the day of the procedure up to 14 days post-procedure.
The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology.
From the day of the procedure up to 14 days post-procedure.
Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate
Time Frame: From the day of the procedure up to 14 days post-procedure.
The proportion of participants with at least one histologically confirmed advanced adenoma (defined as ≥10mm, or with high-grade dysplasia or villous components) or SSA/P.
From the day of the procedure up to 14 days post-procedure.
Patient Satisfaction Score
Time Frame: Assessed within 1 hour after completion of the colonoscopy procedure.
Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied).
Assessed within 1 hour after completion of the colonoscopy procedure.
Physician Satisfaction Score
Time Frame: Assessed within 1 hour after completion of the colonoscopy procedure.
Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied).
Assessed within 1 hour after completion of the colonoscopy procedure.
Incidence of Procedure-Related Adverse Events
Time Frame: From the start of the procedure up to 30 days post-procedure.
The number and type of adverse events (AEs) and serious adverse events (SAEs), including but not limited to perforation, significant bleeding, and infection, are recorded.
From the start of the procedure up to 30 days post-procedure.

Collaborators and Investigators

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

Sponsor

Zhejiang University

Investigators

  • Study Chair: Kefeng Ding, M.D., Ph.D., Second Affiliated Hospital, School of Medicine, Zhejiang University

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)

April 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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