Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting

NCT06160466 | Completed

• 1 other identifier: NP4451
• Study Type: interventional
• Target: 1,156
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

Conditions

Adenoma; Polyp of Colon; Colonic Adenoma

Keywords

ADR; CADe; Follow-up

Outcome Measures

Primary Outcomes (2)

• Adenoma detection rate

  Proportion of patients with at least one histologically confirmed adenoma resected divided by the total number of colonoscopies.

  When available the histological report of polyps removed (up to 3 weeks).

• Rate of patients detected with 3 or more adenomas.

  The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.

  When available the histological report of polyps removed (up to 3 weeks).

Secondary Outcomes (8)

• Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas.

  When available the histological report of polyps removed (up to 3 weeks).

• Size of lesions detected

  Immediately after the procedure.

• Rate of neoplasia by colonic site

  Immediately after the procedure.

• Post-colonoscopy surveilance

  When available the histological report of polyps removed (up to 3 weeks).

• Time of cecal intubation.

  Immediately after the procedure.

Study Arms (2)

Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence.

EXPERIMENTAL

Patients undergoing colonoscopy with artificial intelligence.

Device: CADe colonoscopy using GI Genius device

Conventional Colonoscopy

ACTIVE COMPARATOR

Standard Colonoscopy with white light

Device: White light

Interventions

White light DEVICE

White light endoscopy

Conventional Colonoscopy

CADe colonoscopy using GI Genius device DEVICE

We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a follow-up pateints in the screening population.

Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence.

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program.

You may not qualify if:

• Patients unwilling or unable to give informed consent.
• Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero: lead

Study Sites (1)

Fondazione Poliambulanza

Brescia, Bs, 25124, Italy

Location

MeSH Terms

Conditions

Adenoma; Colonic Polyps

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristiano Spada

  Fondazione Poliambulanza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 16, 2020
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 18, 2026

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)