NCT06767111
Techcyte SureView Cervical Cytology System Clinical Validation Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalTechcyte, Inc.
~4,596 participants
Updated 2025-09-04 on ClinicalTrials.gov
What's tested:Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System
Measured over 1 day
Conditions
Where it's being run
1 sites across 1 statesUtah1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Glass slides with cervical cytology specimens prepared with Hologic ThinPrep according to the pap test manufacturers Instructions for Use (IFU) using any of Hologic's processors (i.e. ThinPrep2000, ThinPrep 3000, ThinPrep 5000, ThinPrep Genesis). OR Glass slides with cervical cytology specimens prepared with BD SurePath according to the pap test manufacturers IFU using any of BD's processors (i.e. BD Totalys MultiProcessor, BD Totalys SlidePrep, BD PrepStain).
Slide has the original diagnosis available.
Slides that fit within the required sample size strata using the sample collection procedure.
Glass slides with QR code, barcodes, or plain text labels.
Glass slides with coverslips.
Slides that are 5 years old or less, except where rare specimens require it. Those specimens will have to be reviewed for degradation per the sample collection procedure.
Only one sample per patient and all are to be collected, processed and scanned.
Exclusion
Broken or cracked slides.
Slides with air bubbles or scratched, cracked or broken/missing cover slips.
Slides with markings (e.g., handwritten pen marking) that cannot be removed according to standard laboratory procedures.
Degraded slides (ex: slides whose stains have lost color or specimens that are not intact).
Glass slides with cervical cytology specimens prepared with methods other than Hologic ThinPrep or BD SurePath.
Glass slides with specimens other than cervical cytology specimens.
Slides from the same patient.
What this trial measures
- Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System1 day
The primary objective of the study is to show that the assessment of LBC pap tests using the Techcyte SureView Cervical Cytology System, i.e. the AI-assisted method, is non-inferior to current standard practice, i.e., the standard method, at the LSIL+ threshold used for cytologic diagnosis (specimen adequacy and descriptive diagnosis) as defined by The Bethesda System for Reporting Cervical Cytology.