Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AI-Assisted Colonoscopy
Treatment groups
3,342 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov