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New device uses light signals to guide breast cancer surgery

NCT ID NCT06020573

Knowledge-focused Sponsor: Erbe Elektromedizin GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed early study tested a special clip-on electrode with fiber optics that detects light signals during breast cancer surgery. The goal was to see if the device is safe and can help surgeons identify different tissue types in real time. Twenty-four women with invasive breast cancer took part. The main focus was on safety, with results used to improve the device for future larger studies.

What this could mean

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

Active substance
Clip-on electrode with fiber optics (device)
What this could lead to
If successful, this device could help surgeons remove breast cancer more accurately, reducing the need for repeat surgeries.
What could go wrong
This is a very early feasibility study with only 24 participants, so results may not apply broadly. The device is still being tested for safety and performance, not yet proven to improve outcomes.

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

24 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 2024

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: 1. Female patient with primary invasive breast cancer (NST or NST with DCIS component, including endocrine pretreatment according to standard of care therapy at the study site) 2. Solid tumor size ≥ 15 mm at screening, on sonography imaging 3. Breast conserving surgery 4. ≥ 18 years of age 5. Ability to provide written informed consent Exclusion Criteria: 1. Neoadjuvant chemotherapy 2. Bilateral breast conserving surgery 3. Invasive lobular carcinoma, DCIS, LCIS 4. Suspicion of extensive DCIS component of NST tumor 5. Diagnosis of recurrent breast cancer 6. Previous radiotherapy 7. Patient is pregnant or lactating 8. Patient is wearing active implant (cardiac pacemaker, internal defibrillator, other active implant), passive implants (hip arthroplasties, tooth implants etc.) are allowed at the discretion of the principal investigator 9. According to physicians' assessment, patient is not able to follow study protocol (e.g., due to cognitive disease) or is not able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma Margins of Excision

As listed by the trial registrant

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

Breast cancer Resection margin

Contacts and locations

Locations

  • Department for Women's Health

    Tübingen, 72076, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.