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Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.

NCT05512793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

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 2 is a multicentric randomized clinical trial with a tandem colonoscopy design. The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal.

Conditions

Interventions

DIAGNOSTIC_TEST

Standard technique First colonoscopy without PolyDeep

Standard technique First colonoscopy without PolyDeep

DIAGNOSTIC_TEST

Combination technique First colonoscopy with PolyDeep

Combination technique First colonoscopy with PolyDeep

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Asociación Española de Gastroenterología

    collaborator OTHER

  • Ministry of Work and Welfare - Xunta de Galicia

    collaborator OTHER_GOV

  • European Regional Development Fund

    collaborator OTHER

  • Fundacin Biomedica Galicia Sur

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2023-07-30
Completion
2023-11-17

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 NCT05512793 on ClinicalTrials.gov