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

NCT07307547 | Not Yet Recruiting

• 1 other identifier: 2025-0756
• Study Type: interventional
• Target: 3,342
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Neoplasms; Colonic Polyp; Adenoma; Colorectal Cancer

Keywords

Artificial Intelligence; Colonoscopy; Colorectal Cancer Screening; Adenoma Detection Rate; Deep Learning

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

  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 Outcomes (5)

• Mean Adenomas Per Colonoscopy (APC)

  From the day of the procedure up to 14 days post-procedure.

• Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate

  From the day of the procedure up to 14 days post-procedure.

• Patient Satisfaction Score

  Assessed within 1 hour after completion of the colonoscopy procedure.

• Physician Satisfaction Score

  Assessed within 1 hour after completion of the colonoscopy procedure.

• Incidence of Procedure-Related Adverse Events

  From the start of the procedure up to 30 days post-procedure.

Study Arms (2)

Experimental: AI-Assisted Colonoscopy

EXPERIMENTAL

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

Control: Conventional Colonoscopy

NO INTERVENTION

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.

Interventions

AI-Assisted Colonoscopy DEVICE

High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.

Experimental: AI-Assisted Colonoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Kefeng Ding, M.D., Ph.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Kefeng Ding, M.D., Ph.D.

CONTACT

+86-13906504783; dingkefeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2025-12

Locations

CN (1)