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Artificial Intelligence for Leaving in Situ Colorectal Polyps.

NCT05500248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 919

Last updated 2025-04-18

No results posted yet for this study

Summary

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

  • Colonic Neoplasms

Interventions

BEHAVIORAL

Leave In Situ

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. This behaviour is recommended by guidelines if the endoscopist is expert in optical diagnosis. In this case the endoscopists will be experts and they will also be helped by the CADx system that has shown to exceed the thresholds requested for use in clinical practice in previous trials.

BEHAVIORAL

Standard

All identified polyps will be removed and sent to pathology.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-31
Completion
2024-08-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500248 on ClinicalTrials.gov