Last reviewed · How we verify

NCT05514301

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

Completed NA Last updated 24 February 2025
What this trial tests

NA trial testing Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection in Colorectal Cancer in 205 participants. Completed in 11 April 2023.

Timeline
30 January 2023
Primary endpoint
15 March 2023
11 April 2023

Quick facts

Lead sponsorFundacin Biomedica Galicia Sur
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment205
Start date30 January 2023
Primary completion15 March 2023
Estimated completion11 April 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundacin Biomedica Galicia Sur — full company profile →

Who can join

Adults 40 to 79, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Optical diagnosis in still images of colorectal polyps: comparison between expert endoscopists and PolyDeep, a Computer-Aided Diagnosis system.
    Davila-Piñón P, Nogueira-Rodríguez A, Díez-Martín AI, Codesido L, et al · · 2024 · cited 3× · PMID 38846970 · DOI 10.3389/fonc.2024.1393815
  2. PolyDeep Advance 1: Clinical Validation of a Computer-Aided Detection System for Colorectal Polyp Detection with a Second Observer Design.
    Davila-Piñón P, Pedrido T, Díez-Martín AI, Herrero J, et al · · 2025 · cited 1× · PMID 40002609 · DOI 10.3390/diagnostics15040458
  3. PolyDeep Advance 1: Clinical Validation of a Computer-Aided Detection System for Colorectal Polyp Detection with a Second Observer Design
    Davila-Piñón P, Pedrido T, Díez-Martín AI, Herrero J, et al · · 2024 · DOI 10.20944/preprints202412.2071.v1
  4. UEG Week 2023 Poster Presentations
    · 2023

Verify or expand the search:

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

Other Fundacin Biomedica Galicia Sur trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05514301.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing