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Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System

NCT05514301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-02-24

No results posted yet for this study

Summary

This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 1 is an unicentric prospective diagnostic tests trial with a paired study design. The hypothesis of the study is that Polydeep, a CAD system, is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy.

Conditions

Interventions

DIAGNOSTIC_TEST

Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection

Both diagnostic interventions will be performed in all patients 1. High definition colonoscopy performed by high experienced endoscopists blinded to Polydeep. 2. Polydeep: a CADe and CADx system. The gold standard will be the histological diagnosis of the lesion.

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Ministry of Work and Welfare - Xunta de Galicia

    collaborator OTHER_GOV

  • Asociación Española de Gastroenterología

    collaborator OTHER

  • European Regional Development Fund

    collaborator OTHER

  • Fundacin Biomedica Galicia Sur

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2023-03-15
Completion
2023-04-11

Countries

  • Spain

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 NCT05514301 on ClinicalTrials.gov