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AI takes on pap smears: could it match human experts?

NCT ID NCT06767111

Diagnosis Sponsor: Techcyte, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares a new AI-assisted digital system to the standard manual method for reading Pap tests. About 4,600 cervical cell samples will be reviewed both ways to see if the AI system is just as good at detecting abnormal cells. The goal is to determine if the AI can help cytotechnologists work more efficiently without sacrificing accuracy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Techcyte SureView Cervical Cytology System (AI-assisted digital imaging device)
What this could lead to
If successful, this could provide a faster, AI-assisted way to read Pap tests that is as accurate as the current manual method, potentially improving lab efficiency.
What could go wrong
This is a large study but still testing a new device; it may not prove non-inferior to standard practice, and AI-assisted reading could miss abnormalities or increase false positives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,596 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Samples collected in the United States

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

autoimmune pulmonary alveolar proteinosis pulmonary alveolar proteinosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cytology PAP

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Techcyte

    Orem, Utah, 84057, United States

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