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New Bra-Like device could make breast cancer surgery more precise

NCT ID NCT04397185

Symptom relief Sponsor: CairnSurgical, 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tested a new device called the Breast Cancer Locator (BCL), a custom plastic bra that helps surgeons find tumors during breast-conserving surgery. It was compared to the standard wire localization method in 480 women with non-palpable breast cancer. The goal was to see if the BCL could reduce the rate of positive margins (cancer cells at the edge of removed tissue) and the need for repeat surgeries.

What this could mean

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

Active substance
Breast Cancer Locator (BCL) device
What this could lead to
If successful, this device could make breast-conserving surgery more precise, reducing the need for repeat surgeries and improving cosmetic outcomes.
What could go wrong
This is a completed trial comparing a device to standard care, so results are already in. The device may not show significant improvement over wire localization, and benefits may vary by patient.

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

480 people

The number who actually took part.

Started

Dec 2020

Finished

Dec 2025

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: * Female gender * Age \> 18 years * Histologic diagnosis of invasive breast cancer or DCIS * The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation * The tumor is unifocal or multifocal with satellite lesions \< or = 2 cm from primary tumor * The tumor enhances on prone breast MRI imaging * The tumor is ≥ 1 cm in diameter on prone breast MRI * Subject and surgeon agree to perform BCS * Subject voluntarily provides informed consent Exclusion Criteria: * Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia that precludes prone or supine MRI * Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed * Subjects who have received or plan to receive neoadjuvant chemotherapy * Sternal notch to nipple distance of \> 32 cm as measured in a sitting or standing position * Measurement of widest circumference around breasts and arms \> 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners * Subjects with known allergy to materials present in the device * Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe) * Subject would require \> 2 localization wires, if randomized to standard of care * Subjects with multicentric tumors (additional tumors \> 2 cm from primary) * Subject would require chest wall muscle nerve block as part of the operation

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Conditions

The condition(s) this trial relates to.

ductal breast carcinoma in situ female breast carcinoma invasive 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

  • Arizona Center for Cancer Care

    Scottsdale, Arizona, 85258, United States

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Basildon University Hospital

    Basildon, United Kingdom

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Cheshire Medical Center

    Keene, New Hampshire, 03431, United States

  • Columbia University Irving Medical Center and New York-Presbyterian Hospital

    New York, New York, 10032, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Hennepin Healthcare

    Minneapolis, Minnesota, 55415, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Kent Hospital

    Warwick, Rhode Island, 02886, United States

  • LKH Feldkirch

    Feldkirch, Austria

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Manchester University NHS

    Manchester, United Kingdom

  • Mass General/North Shore Center for Outpatient Care

    Danvers, Massachusetts, 01923, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rutland Regional Medical Center

    Rutland, Vermont, 05701, United States

  • St. Joseph Hospital

    Nashua, New Hampshire, 03060, United States

  • St. Peter's Hospital

    Albany, New York, 12208, United States

  • Steward Medical Group

    Easton, Massachusetts, 02356, United States

  • Summit Health

    Florham Park, New Jersey, 07932, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

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