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Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy

NCT04965857 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2023-07-05

No results posted yet for this study

Summary

Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach

Conditions

  • Cervical Cancer Screening

Interventions

DIAGNOSTIC_TEST

Hologic's Genius Digital Diagnostics System

Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.

Sponsors & Collaborators

  • Hologic Deutschland GmbH

    lead INDUSTRY

Eligibility

Min Age
35 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

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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 NCT04965857 on ClinicalTrials.gov