Using AI and a special device to improve detection of colorectal cancer
Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
NA · Chinese University of Hong Kong · NCT05414448
This study is testing if using a special device with artificial intelligence can help doctors find more polyps during colonoscopies in patients getting screened for colorectal cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1726 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Shatin, Hong Kong Island) |
| Trial ID | NCT05414448 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining an artificial intelligence system (ENDOAID) with a mucosal exposure device (Endocuff Vision®) to enhance the detection of colorectal neoplasia, particularly adenomas. The study aims to address the high rates of missed polyps during standard colonoscopies, which can lead to interval colorectal cancer. By employing a randomized controlled trial design, participants will be evaluated to determine if the combined approach improves adenoma detection rates compared to using the AI system alone. The trial focuses on patients undergoing elective colonoscopy for screening or surveillance.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45-85 who require elective colonoscopy for colorectal cancer screening or related symptoms.
Not a fit: Patients with contraindications to colonoscopy or a personal history of colorectal cancer or inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of missed colorectal lesions, leading to earlier detection and treatment of colorectal cancer.
How similar studies have performed: While the combination of AI and mucosal exposure devices is a novel approach, previous studies have shown that mucosal exposure devices can improve detection rates in colonoscopy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 45-85 years old; 2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit; 3. Written informed consent obtained. Exclusion Criteria: 1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation) 2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets) 3. Staged procedure for polypectomy or biopsy of known unresected lesions 4. Previous surgical resection of colon 5. Personal history of colorectal cancer 6. Personal history of familial polyposis syndrome 7. Personal history of inflammatory bowel disease 8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) 9. Pregnancy 10. Unable to obtain informed consent
Where this trial is running
Shatin, Hong Kong Island
- Prince of Wales Hospital — Shatin, Hong Kong Island, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Felix Sia
- Email: felixsia@cuhk.edu.hk
- Phone: 26370428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adenoma, Colorectal Cancer, Colorectal Neoplasms