NCT05500248

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
919

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

April 18, 2025

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

August 11, 2022

Last Update Submit

April 15, 2025

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Adenoma Detection Rate (ADR)

    the proportion of participants with at least one adenoma (per-patient analysis) in the two arms

    1 year

Secondary Outcomes (2)

  • Adenoma Detection Rate (ADR) in the rectosigmoid tract.

    1 year

  • Positive Predictive Value (PPV)

    1 year

Study Arms (2)

Leave-In-Situ Arm

EXPERIMENTAL

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.

Behavioral: Leave In Situ

Standard arm

ACTIVE COMPARATOR

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.

Behavioral: Standard

Interventions

Leave In SituBEHAVIORAL

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.

Leave-In-Situ Arm
StandardBEHAVIORAL

All identified polyps will be removed and sent to pathology.

Standard arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All \>18 years-old patients undergoing elective colonoscopy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Dei Castelli

Ariccia, Rome, 00040, Italy

Location

Related Publications (1)

  • Antonelli 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: 40914178DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

October 1, 2022

Primary Completion

December 31, 2023

Study Completion

August 30, 2024

Last Updated

April 18, 2025

Record last verified: 2024-10

Locations

IT(1)