Clinical trial · Interventional
Characterization of Colorectal Neoplasia
The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GI Genius CADx device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GI Genius CADx device
- interventionNames
- Device: GI Genius CADx device
Primary outcomes (1)
- measure
- Negative Predictive Value (NPV)
- timeFrame
- 4 months
- description
- Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 40 years or older undergoing screening colonoscopy for CRC * Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation Exclusion Criteria: * subjects at high risk for colorectal cancer * subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes * patients with previous resection of the sigmoid rectum * patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings * patients who perform an emergency colonoscopy
References
Publications (2)
- DERIVEDBrenner TA, Labaki C, Feuerstein JD, Berzin TM. Prospective Validation of the First US FDA-Approved Computer-Aided Quality Assessment Tool for Colonoscopy: An Initial Clinical Experience. Am J Gastroenterol. 2026 Apr 1;121(4):1036-1040. doi: 10.14309/ajg.0000000000003855. Epub 2025 Nov 19. PMID 41257531
- DERIVEDHassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11. PMID 35835342