Techcyte SureView Cervical Cytology System Clinical Validation Study

Conditions

• Cervical Cytology
• PAP

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Dec 1, 2024

Status verified

Sep 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

4,596 participants (estimated)

Primary Outcome Measure

Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System [ Time Frame: 1 day ]

Locations (1)

Find similar trials in Orem, UT