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New heat treatment could zap small breast tumors without surgery

NCT ID NCT04389216

Disease control Sponsor: Hospital Universitari de Bellvitge 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a device that uses heat (radiofrequency ablation) to destroy small breast tumors (less than 2 cm). Thirty women with early-stage breast cancer received the treatment to see if it could safely eliminate the tumor. The goal was to find a less invasive option than standard surgery.

What this could mean

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

Active substance
Radiofrequency ablation device (cool-tip electrode)
What this could lead to
If successful, this could offer a less invasive treatment option for small breast tumors, potentially reducing the need for surgery.
What could go wrong
This was a small, early-stage study with only 30 participants. The results may not apply to all breast cancer patients, and there is a risk of incomplete tumor destruction or side effects from the procedure.

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

30 people

The number who actually took part.

Started

May 2020

Finished

Sep 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

65 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.

Inclusion Criteria: * Infiltrating ductal carcinoma according the biopsy of the breast, * Tumor visible by ultrasound, smaller than 2 cm, * Located \> 1 cm from the chest wall and the skin. Exclusion Criteria: * Personal antecedents of breast cancer * Multifocality or intraductal carcinoma * Lobular infiltrating carcinoma * Neoadjuvant therapy

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Conditions

The condition(s) this trial relates to.

female breast carcinoma invasive ductal breast carcinoma

As listed by the trial registrant

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

Breast cancer female

Contacts and locations

Locations

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

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