Medical-AI trial: can AI-assisted colonoscopy increase detection of adenomas (precancerous lesions)? vs. standard (randomized controlled trial) (NCT07066046)
A randomized controlled trial (RCT) evaluating whether AI-assisted colonoscopy raises the adenoma detection rate (ADR) and improves the accuracy of characterizing colorectal lesions (telling benign from malignant), compared with standard colonoscopy. The primary outcome is the proportion of patients with at least one histologically confirmed adenoma (AI vs. control). Target 1,000; recruiting.
Trial overview (primary data)
- StatusRecruiting
- ConditionsColorectal Cancer (CRC), Adenomatous Polyposis, Colorectal Lesions, Colorectal Cancer
- InterventionsPROCEDURE: Colonoscopy
- SponsorInstituto do Cancer do Estado de São Paulo
- Target enrollment1,000 participants
- Period2025-02-01 〜 2026-12-01
Key points
- An RCT of whether AI-assisted colonoscopy raises the adenoma detection rate (ADR) and improves lesion characterization accuracy vs. standard colonoscopy.
- Primary outcome is the proportion of patients with at least one histologically confirmed adenoma (AI vs. control).
- Most colorectal cancers arise from adenomas (precancerous lesions); finding and removing them at colonoscopy aids prevention.
- Small, flat adenomas are easily missed; real-time AI flagging may help detection.
- Target 1,000; recruiting. An evaluation stage, not an establishment of a specific device effectiveness or replacement of the standard.
Most colorectal cancers arise slowly from adenomas, precancerous lesions that are a type of polyp. Finding and removing adenomas at colonoscopy can prevent cancer. But small, flat adenomas are easy to miss, and how many are caught (the adenoma detection rate, ADR) depends on operator skill and concentration. If AI analyzes the image in real time and flags suspicious lesions, it might reduce misses.
This study tests AI-assisted colonoscopy in a randomized controlled trial (RCT). Per the registry summary, it compares AI-assisted with standard colonoscopy to evaluate whether AI can (1) raise the adenoma detection rate (ADR) and (2) improve the accuracy of characterizing colorectal lesions (telling benign from malignant).
The primary outcome is the proportion of patients with at least one adenoma confirmed by histopathology during colonoscopy, compared between the AI and control groups. The target is 1,000 patients, and it is recruiting.
AI support for colonoscopy (CADe for detecting lesions and CADx for characterizing them) is among the most deployed areas of medical AI, and the adenoma detection rate is a leading measure of colorectal-cancer-prevention quality. Comparing it head-to-head against standard colonoscopy in an RCT positions this study to confirm, as evidence, whether AI actually reduces misses and aids prevention.
That said, this trial is at the evaluation stage; it does not establish the effectiveness of a specific device or replacement of the standard method.
Why it matters
AI support for colonoscopy (CADe/CADx) is one of the most deployed medical-AI areas. Comparing the adenoma detection rate against the standard in an RCT is a useful way to confirm, as evidence, whether AI reduces misses and aids prevention (this trial is at the evaluation stage, not an establishment of effectiveness).
FAQ
What is the adenoma detection rate (ADR)?
Does AI replace the doctor colonoscopy?
Sources (primary)
Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT07066046