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New heat treatment and AI could revolutionize cervical cancer prevention

NCT ID NCT07461818

Disease control Sponsor: Basic Health International, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study in El Salvador tests a new thermal ablation device (IRIS™) to treat cervical precancer and an AI algorithm to help decide who needs treatment. About 5,000 HPV-positive women aged 30-49 will receive the treatment and be followed for one year to see if the precancer is cured. The goal is to make screening and treatment faster and more effective.

What this could mean

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

Active substance
IRIS™ Thermal Ablation Device
What this could lead to
If successful, this could provide a more effective and efficient way to treat cervical precancer and triage HPV-positive women, potentially reducing cervical cancer rates.
What could go wrong
This is a single-country study with no control group, so results may not apply elsewhere. The AI triage algorithm is still being tested and may not be accurate enough for widespread use.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5,000 people

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

Started

Jan 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

30 to 49 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women aged 30-49 years * Non-pregnant (determined by urine pregnancy test) * HPV-positive per Ministry of Health (MOH) records * Willing to undergo colposcopy and biopsies * Able and willing to provide informed consent Exclusion Criteria: * Plans to become pregnant during the study * History of LEEP or cervical ablation procedure in the past 5 years * History of total hysterectomy (verified by medical record or pelvic evaluation) * History of cervical cancer * Unable or unwilling to provide a permanent and reliable address * Unable or unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 dysplasia of cervix human papilloma virus infection Uterine Cervical Neoplasms

As listed by the trial registrant

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

Cervical intraepithelial neoplasia Cervical precancer Human papillomavirus infection

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

  • Basic Health International

    RECRUITING

    San Salvador, San Salvador Department, El Salvador

    Contact Email: •••••@•••••

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