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Clinical Trial NCT07307547 (AI-COLOSCREEN) for Colorectal Neoplasms, Colonic Polyp, Adenoma, Colorectal Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Zhejiang UniversityEfficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN) 3,342 Randomized Multi-Center
Clinical Trial NCT07307547 (AI-COLOSCREEN) is an interventional study for Colorectal Neoplasms, Colonic Polyp, Adenoma, Colorectal Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 3,342 participants. Led by Zhejiang University, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 10 February 2026.
Brief Summary
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...Show More
Detailed 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 screen...Show More
Official Title
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.
Conditions
Colorectal NeoplasmsColonic PolypAdenomaColorectal CancerOther Study IDs
- AI-COLOSCREEN
- 2025-0756
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-02-10
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
3,342
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Artificial Intelligence
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
Primary Purpose
Screening
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental: 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 endoscopist in identifying and highlighting suspicious lesions. | AI-Assisted Colonoscopy High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system. |
No InterventionControl: Conventional Colonoscopy 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Adenoma Detection Rate (ADR) | The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports. | From the day of the procedure up to 14 days post-procedure. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean Adenomas Per Colonoscopy (APC) | The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology. | From the day of the procedure up to 14 days post-procedure. |
Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate | The proportion of participants with at least one histologically confirmed advanced adenoma (defined as ≥10mm, or with high-grade dysplasia or villous components) or SSA/P. | From the day of the procedure up to 14 days post-procedure. |
Patient Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Physician Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Incidence of Procedure-Related Adverse Events | The number and type of adverse events (AEs) and serious adverse events (SAEs), including but not limited to perforation, significant bleeding, and infection, are recorded. | From the start of the procedure up to 30 days post-procedure. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
- Women who are pregnant, planning to become pregnant, or are breastfeeding.
- Participation in another interventional clinical trial within the 30 days prior to enrollment.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
Zhejiang University1067 active studies to exploreStudy Responsible Party
Ding Ke-Feng, Principal Investigator, Clinical professor, Zhejiang University
Study Central Contact
Contact: Kefeng Ding, M.D., Ph.D., +86-13906504783, [email protected]
1 Study Locations in 1 Countries
Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Kefeng Ding, M.D., Ph.D., Contact, +86-13906504783, [email protected]