Clinical trial · Interventional
Artificial Intelligence for Leaving in Situ Colorectal Polyps.
Impact of Computer-aided Optical Diagnosis (CADx) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial.
- 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 two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.
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 Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leave In Situ | Behavioral | — | UNRESOLVED |
| Standard | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Leave-In-Situ Arm
- description
- standard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
- interventionNames
- Behavioral: Leave In Situ
- type
- ACTIVE_COMPARATOR
- label
- Standard arm
- description
- standard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
- interventionNames
- Behavioral: Standard
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: \- All \>18 years-old patients undergoing elective colonoscopy Exclusion criteria: * patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD). * Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis. * patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment). * patients with previous colonic resection. * patients on antithrombotic therapy, precluding polyp resection. * patients who were not able or refused to give informed written consent.
References
Publications (1)
- DERIVEDAntonelli G, Desideri F, Scarozza P, Andrisani G, Zerboni G, Furnari M, Bevilacqua N, Cossignani M, Di Fonzo M, Cereatti F, Navazzotti G, Antenucci C, Di Matteo FM, Bevivino G, Caruso A, Spadaccini M, Schiavone S, Grossi C, Rizkala T, Comberlato M, Bretthauer M, Sharma P, Von Renteln D, Rex DK, Correale L, Repici A, Mori Y, Iacopini F, Hassan C. Safety of artificial intelligence-assisted optical diagnosis for leaving colorectal polyps in situ during colonoscopy (PRACTICE): a non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):915-923. doi: 10.1016/S2468-1253(25)00140-2. PMID 40914178