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Can a portable heat device match cryotherapy for cervical precancer?

NCT ID NCT03429582

Disease control Sponsor: The Cleveland Clinic 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial tests whether portable thermal ablation devices, designed for low-resource settings, can treat cervical precancer as effectively as standard cryotherapy. Women aged 18 and older with high-grade cervical precancer will receive either cryotherapy or thermal ablation with single or multiple tips. The study compares cure rates one year after treatment and also measures pain and quality of life. If the heat-based devices work as well, they could offer a more accessible treatment option in areas with limited healthcare resources.

What this could mean

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

Active substance
Thermal ablation device (single or multiple tips) compared to standard CO2 cryotherapy
What this could lead to
If successful, this could provide a portable, low-cost alternative to cryotherapy for treating cervical precancer in low- and middle-income countries, expanding access to care.
What could go wrong
The trial is early and results may not confirm non-inferiority. There are risks of pain, bleeding, or incomplete treatment, and outcomes may not generalize beyond the study setting.

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

1,154 people

The number who actually took part.

Started

Oct 2020

Finished

Jul 2025

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

18 years and older

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.

Criteria for inclusion * Women aged 18 and older * Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified * Willing and able to provide informed consent * Willing and able to provide permanent or reliable address Criteria for exclusion * Pregnant or plans to become pregnant during study * History of total hysterectomy (verified by medical record or pelvic evaluation) * Previous surgery destructive to the cervix within the last 5 years * Patient not eligible for cryotherapy or thermoablation (lesion \>75% of cervix, lesion extends into canal or there is suspicion for invasive cancer) * Cervix shape disfigured or hard to reach

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Conditions

The condition(s) this trial relates to.

cervical intraepithelial neoplasia cervical intraepithelial neoplasia grade 2/3 dysplasia of cervix

As listed by the trial registrant

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

Cervical intraepithelial neoplasia

Contacts and locations

Locations

  • Hospital Nacional de la Mujer

    San Salvador, El Salvador

  • Peking University Shenzhen Hospital

    Shenzhen, China

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