MedTrace Logo

Computer-aided Detection During Screening Colonoscopy

NCT05734820 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2023-09-28

No results posted yet for this study

Summary

Nowadays, colonoscopy is considered the gold standard for the detection of lesions in the colorectal mucosa. However, around 25% of polyps may be missed during the conventional colonoscopy. Based on this, new technological tools aimed to improve the quality of the procedures, diminishing the technical and operator-related factors associated with the missed lesions. These tools use artificial intelligence (AI), a computer system able to perform human tasks after a previous training process from a large dataset. The DiscoveryTM AI-assisted polyp detector (Pentax Medical, Hoya Group, Tokyo, Japan) is a newly developed detection system based on AI. It was designed to alert and direct the attention to potential mucosal lesions. According to its remarkable features, it may increase the polyp and adenoma detection rates (PDR and ADR, respectively) and decrease the adenoma miss rate (AMR).

Based on the above, the investigators aim to assess the real-world effectiveness of the DiscoveryTM AI-assisted polyp detector system in clinical practice and compare the results between expert (seniors) and non-expert (juniors) endoscopists.

Conditions

Interventions

DIAGNOSTIC_TEST

HD- colonoscopy

HD-colonoscopy performed by an expert or non-expert endoscopist. All lesions will be recorded, assessed, and removed for histological analysis.

DIAGNOSTIC_TEST

HD-colonoscopy assisted by AI

HD-colonoscopy with AI-assisted polyp detector. New polyps detected by AI will be recorded, removed, and studied.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos Robles-Medranda, MD FASGE · Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-11
Primary Completion
2024-06-11
Completion
2024-09-01

Countries

  • Ecuador

Study Locations

More Related Trials

Entities

Diseases

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 NCT05734820 on ClinicalTrials.gov