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Laser zaps small breast tumors, no scalpel needed

NCT ID NCT03463954

Disease control Sponsor: Novian Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests a laser device called Novilase that destroys small breast tumors (≤15 mm) using heat, without cutting them out. About 122 women will receive the laser treatment, and researchers will check if it works as well as standard lumpectomy. The goal is to see if this less invasive approach can reduce the need for repeat procedures and speed up recovery.

What this could mean

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

Active substance
Novilase laser ablation device
What this could lead to
If successful, this could offer a non-surgical option for small breast tumors, with quicker recovery and less scarring than lumpectomy.
What could go wrong
This is a mid-stage study with 122 participants, so results may not apply to everyone. Risks include incomplete ablation, infection, or cosmetic issues.

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 122 people

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

Started

Aug 2023

Expected to finish

Mar 2027

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.

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.

Inclusion Criteria: * Females, aged 18 years and older * Able to give written informed consent herself * Definitive pathologic diagnosis by needle core biopsy * Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic * No more than 10 mm of calcifications confined to the tumor on imaging * Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images) * Tumor is well visualized on MRI * Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site * Tumor with less than 25% intraductal component, as determined by core biopsy * No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy * Subject weight limited to ≤300 lbs. or ≤136 kg * Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician Exclusion Criteria: * Subject younger than 18 years of age * Pregnant or breast-feeding * Tumor poorly visualized by ultrasound or x-ray mammography imaging * Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) \<30ml/min/1.73 sq. meters) * Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants) * History of severe asthma * Tumor measuring greater than 15 mm in longest dimension * Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm. * Advanced stage breast cancer * Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease * Tumor with only DCIS with microinvasion * Extensive intraductal component in lesion (i.e., \>25%) as determined by core biopsy * Subject who is known to be BRCA positive * Tumor that is ER/PR/HER2 negative (TNBC) * Inability to lie in prone or supine position for one hour * Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial * Subject without a definitive HER2 test according to ASCO/CAP guidelines

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Malignant neoplasm of breast

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

    10 sites in 5 countries. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Breast Centre Zurich

    TERMINATED

    Zurich, 8008, Switzerland

  • Buffalo General Medical Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Charing Cross Hospital, Imperial College Healthcare NHS Trust

    RECRUITING

    London, United Kingdom

  • Churchill Hospital, Oxford University Hospitals NHS Trust

    RECRUITING

    Oxford, United Kingdom

  • City of Hope

    WITHDRAWN

    Duarte, California, 91010, United States

  • Eisenhower Health

    RECRUITING

    Rancho Mirage, California, 92270, United States

  • Ichilov | Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Israel

  • St. Elisabeth-Krankenhaus Köln-Hohenlind

    RECRUITING

    Cologne, 50935, Germany

  • Summit Health

    NOT_YET_RECRUITING

    Florham Park, New Jersey, 07932, United States

  • UC San Diego Health

    RECRUITING

    La Jolla, California, 92037, United States

  • University Hospital Zurich

    RECRUITING

    Zurich, 8091, Switzerland

  • Walter Reed National Military Medical Center

    WITHDRAWN

    Bethesda, Maryland, 20889, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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