Clinical trial · Interventional
Effectiveness of Artificial Intelligence-Assisted Colonoscopy for Adenoma Detection in Routine Clinical Practice : a Prospective Multicenter Randomized Trial
A Multi-center, Randomized, Controlled Clinical Study on the Effectiveness of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions in Routine Clinical Practice Across Tertiary Academic Medical Centers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colonic Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Assisted Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: AI-Assisted Colonoscopy
- description
- 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.
- interventionNames
- Device: AI-Assisted Colonoscopy
- type
- NO_INTERVENTION
- label
- Control: Conventional Colonoscopy
- description
- 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.
Primary outcomes (1)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
- From the day of the procedure up to 14 days post-procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 40 to 74 years, inclusive; men and women. 2. Scheduled for elective screening, diagnostic, or surveillance colonoscopy. 3. In generally good condition, mentally competent, and willing to provide written informed consent. Exclusion Criteria: 1. Known contraindication to colonoscopy or to biopsy. 2. History of colon cancer or previous colonic surgery. 3. Bowel obstruction; confirmed or highly suspected colorectal cancer; inflammatory bowel disease; or active colorectal bleeding. 4. Colorectal polyposis, including a history of familial adenomatous polyposis. 5. Pregnancy or breastfeeding. 6. Participation in another drug or medical device clinical trial within 1 month before enrollment. 7. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this trial. Withdrawal Criteria: 1. Withdrawal of consent by the participant. 2. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score below 6 or any segment score below 2. 3. Failure to reach the cecum. 4. Newly diagnosed active colitis during the procedure.
References
Publications (0)
Data not yet available