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Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3

NCT05513261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 857

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 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with PolyDeep assisted high definition colonoscopy. The hypothesis of the study is that the PolyDeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).

Conditions

Interventions

DIAGNOSTIC_TEST

High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate

In the intervention of this arm the investigators will apply the standard colonoscopy without computer-aided colonoscopy (polyDeep)

DIAGNOSTIC_TEST

PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate

In the intervention of this arm the investigators will apply polyDeep assisted high definition colonoscopy (CAD system).

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
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2024-03-08
Completion
2024-05-14

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 NCT05513261 on ClinicalTrials.gov