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Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System

NCT05000125 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1994

Last updated 2022-04-15

No results posted yet for this study

Summary

Quality assurance of the laboratory examinations. Retrospective non-interventional study with ThinPrep slides collected as part of the German Co-Screening Program for routine diagnostic. These slides will retrospectively be used to validate the Hologic Genius Digital Cytology (DC) system vs. the ThinPrep Imaging system (TIS).

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
Yes

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2021-09-27
Completion
2021-12-31

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 NCT05000125 on ClinicalTrials.gov