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

Zhejiang University

Status: Not yet enrolling

Conditions: Colonic Polyp; Colorectal Neoplasms; Adenoma; Colorectal Cancer

Treatments: Device: AI-Assisted Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07307547

2025-0756

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,342 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,342 participants in 2 patient groups

Experimental: AI-Assisted Colonoscopy

Experimental group

Description:

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.

Treatment:

Device: AI-Assisted Colonoscopy

Control: Conventional Colonoscopy

No Intervention group

Description:

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.