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

NCT04441580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-04-10

No results posted yet for this study

Summary

Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination. Artificial intelligence seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. 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.

The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC).

Conditions

  • Colonic Neoplasms
  • Colonic Adenocarcinoma
  • Polyps of Colon
  • Rectal Neoplasms
  • Rectal Adenocarcinoma

Interventions

DEVICE

CADe colonoscopy using GI Genius device

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

Sponsors & Collaborators

  • Fondazione Poliambulanza Istituto Ospedaliero

    lead OTHER

Principal Investigators

  • Cristiano Spada, MD, PhD · Fondazione Poliambulanza Istituto Ospedaliero

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2023-10-31
Completion
2023-12-31

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 NCT04441580 on ClinicalTrials.gov