Evaluating a computer-aided system for measuring colorectal polyp sizes

Performance Evaluation of a Computer-aided Measuring System for Colorectal Polyp Size Measurement: a Prospective Study

This study is testing a new computer program to see if it can measure the size of colorectal polyps more accurately during colonoscopy compared to traditional methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Changhai Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06715384 on ClinicalTrials.gov

What this trial studies

This study aims to assess the accuracy of a computer-aided measuring (CAM) system for colorectal polyp size measurement during colonoscopy. It will be conducted in two phases: the first phase involves analyzing clinical videos to compare the CAM system's measurements with traditional methods, while the second phase will be a randomized controlled trial comparing AI-assisted measurements to non-scaled device assessments. The goal is to improve polyp size measurement accuracy, which is crucial for patient management and treatment decisions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 undergoing colonoscopy for screening, surveillance, or diagnostic purposes.

Not a fit: Patients with anticoagulant use, inflammatory bowel disease, or those requiring emergency colonoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of polyp size measurements, leading to better risk stratification and treatment planning for patients.

How similar studies have performed: Other studies have shown promise in using artificial intelligence for medical imaging, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18-75, any gender; 76-85 years eligible case-by-case based on health status.
2. Colonoscopy screening, surveillance, or diagnostic participants.
3. Informed consent obtained.

Exclusion Criteria:

1. Anticoagulant use (e.g., aspirin, warfarin) within 7 days prior to colonoscopy or coagulopathy.
2. Inflammatory bowel disease.
3. Aronchick score \>3 at entry.
4. Incomplete Case Report Form (CRF) data.
5. Emergency colonoscopy.
6. Pregnancy or lactation.
7. Gastrointestinal obstruction.
8. Refusal to participate.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital, Naval Medical University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Sheng-Bing Zhao, MD — Department of Gastroenterology, National Clinical Research Center for Digestive Diseases, Changhai Hospital, Naval Medical University, Shanghai 200433, China.
• Study coordinator: Cheng-Long Wang, MD

Conditions: Colorectal Polyp, Colorectal Adenoma, Artificial Intelligence, Polyp Size, Deep Learning, Colonoscopy, Depth Map