NCT06767111

Techcyte SureView Cervical Cytology System Clinical Validation Study

Multi-center, Two-arm Clinical Study Evaluating the Performance of the Techcyte Sureview Cervical Cytology System and Its Subsystems for the Assessment of Pap Tests

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 4,596 (estimated)
• Sponsor: Techcyte, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a reference. The control method is defined as the assessment of LBC pap tests performed by a cytotechnologist (CT) and/or cytopathologist (CP) using standard laboratory cervical cytology practices (i.e. a manual assessment) and following The Bethesda System for Reporting Cervical Cytology (TBS). The control method is referred to as the "standard method". The test method is referred to as the AI-assisted method. The AI-assisted method is defined as the assessment of the same LBC pap test as in the standard method, but with the Techcyte SureView Cervical Cytology System, which has pap tests being scanned on the Pramana SpectralHT Cubiq whole slide scanner, analyzed with the Techcyte Cervical Cytology Algorithm (TCCA) and presented on the Techcyte Viewer, using the Dell U3223QE Monitor for assessment by a CT/CP following the TBS. In addition, the time spent reviewing the samples with both methods will be measured such that the CT workload limit for AI-assisted assessment can be established. The LBC pap tests to be assessed in the clinical study must have been prepared with either ThinPrep® Pap Test (Hologic) or BD SurePath™ (Beckton, Dickinson and Company). The study aims to enroll for each preparation method an equal number of samples.

Conditions

• Cervical Cytology
• PAP

Interventions

Type	Name	Description
DEVICE	Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device	Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm to be used for AI-assisted review

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-01-09
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States