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NCT05500248

Artificial Intelligence for Leaving in Situ Colorectal Polyps.

Completed NA Last updated 18 April 2025
What this trial tests

NA trial testing Leave In Situ in Colonic Neoplasms in 919 participants. Completed in 30 August 2024.

Timeline
1 October 2022
Primary endpoint
31 December 2023
30 August 2024

Quick facts

Lead sponsorUniversity of Roma La Sapienza
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment919
Start date1 October 2022
Primary completion31 December 2023
Estimated completion30 August 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Roma La Sapienza

Who can join

18 and older, any sex, with Colonic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Safety of artificial intelligence-assisted optical diagnosis for leaving colorectal polyps in situ during colonoscopy (PRACTICE): a non-inferiority, randomised controlled trial.
    Antonelli G, Desideri F, Scarozza P, Andrisani G, et al · · 2025 · PMID 40914178 · DOI 10.1016/s2468-1253(25)00140-2

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Other recruiting trials for Colonic Neoplasms

Currently open trials in the same condition.

Other University of Roma La Sapienza trials

Trials by the same sponsor.

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Data sources for this page

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