Cervical CytologyNCT06767111
Techcyte SureView Cervical Cytology System Clinical Validation Study
An observational study of Cervical Cytology and PAP, run by Techcyte, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cytology, PAP
- What is being tested?
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Type of treatment
- Medical device
- How many people
- 4,596 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples collected in the United States
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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".
Read more
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
- Being tested
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Keywords
- in vitro diagnostic device, IVD, AI, whole slide scanner, pap test slide, pap, cervical cytology, digital pathology, digital cytopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) deviceDevice
Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm to be used for AI-assisted review
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CytologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Techcyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767111
- Sponsor's protocol ID
- 1-VAL-3427
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06767111
- Acronym / sponsor ID
- 1-VAL-3427
- Conditions
- Cervical Cytology, PAP
- Keywords
- in vitro diagnostic device, IVD, AI, whole slide scanner, pap test slide, pap, cervical cytology, digital pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,596 participants (actual)
- Lead sponsor
- Techcyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples collected in the United States
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) deviceDigital cervical cytology slide imaging system with artificial intelligence (AI) algorithm to be used for AI-assisted review | Device | – |
Primary outcome
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System
Time frame: 1 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BackgroundNayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cytology and PAP, run by Techcyte, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity when comparing pap tests using the Techcyte SureView Cervical Cytology System (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.