Trials / Completed
CompletedNCT05000125
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System
Comparison of the Hologic Genius Digital Diagnostics System With the ThinPrep Imaging System - a Retrospective Assessment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,994 (actual)
- Sponsor
- Hologic Deutschland GmbH · Industry
- Sex
- Female
- Age
- 35 Years – 90 Years
- Healthy volunteers
- Accepted
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).
Detailed description
The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to retrospectively validate the Hologic Genius Digital Cytology (DC) system selected slides earlier measured with TIS will be additionally reviewed with the Genius Digital Diagnostic System in order to demonstrate clinical performance and efficiency. Hologic's Digital Image Analysis Algorithm uses AI to identify diagnostically relevant objects of interest.Only anonymized results will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-08-20
- Primary completion
- 2021-09-27
- Completion
- 2021-12-31
- First posted
- 2021-08-11
- Last updated
- 2022-04-15
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05000125. Inclusion in this directory is not an endorsement.