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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

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. - AI-COLOSCREEN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120208
Enrollment
Unknown
Registered
2026-03-10
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer and Precancerous Lesions

Interventions

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 endoscopi
Control: Conventional Colonoscopy:Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence

Sponsors

The Second Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Sensitivity of lesion-level polyp detection,;Specificity of patient-level polyp detection;

Secondary

MeasureTime frame
Sensitivity of patient-level polyp detection;polyp detection rate and polyps per colonoscopy;adenoma detection rate and adenomas per colonoscopy;Independent performance evaluation of the software;Boston Bowel Preparation Scale;Colonoscopy procedure duration;Software usability;Software stability;

Countries

China

Contacts

Public ContactZhanhuai Wang

The Second Affiliated Hospital, Zhejiang University School of Medicine

Wangzhanhuai@zju.edu.cn+86 136 5664 5121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026