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AR goggles could help surgeons remove breast tumors more accurately

NCT ID NCT07003841

Disease control Sponsor: SKIA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an augmented reality (AR) system called SKIA-Breast can help surgeons locate and remove breast tumors as well as the standard ultrasound method. About 94 women with breast cancer will be randomly assigned to have surgery guided by either AR or ultrasound. The main goal is to see if the AR approach leads to clear surgical margins, reducing the chance of leftover cancer cells and the need for additional surgery.

What this could mean

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

Active substance
Augmented reality (AR) surgical navigation software (SKIA-Breast) used with CT imaging
What this could lead to
If successful, this AR system could help surgeons remove breast tumors more precisely during breast-conserving surgery, potentially reducing the need for repeat surgeries.
What could go wrong
This is an early-stage, 94-person trial comparing AR to standard ultrasound. The technology may not prove superior or could have technical limitations in real-world use.

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 94 people

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

Started

Nov 2025

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

19 to 80 years

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: * Subjects will be enrolled only when all the inclusion criteria are fully met. 1. Subjects who aged 19 to 80 years diagnosed with breast cancer through biopsy. 2. Subjects diagnosed with breast cancer who had both MRI and CT and ultrasound scans. 3. Patients diagnosed with breast cancer who are scheduled to undergo breast-conserving surgery, have not received neoadjuvant chemotherapy, and show no evidence of metastasis to other organs. 4. Tumor size criteria on ultrasound: : 5 mm ≤ tumor size ≤ 30 mm 5. Subjects whose biopsy pathology results are Invasive carcinoma. 6. Subjects who have a single lesion. 7. Subjects who have received a full explanation of the clinical trial fully understand its details, voluntarily decide to participate, and provide written informed consent. Exclusion Criteria: * Subjects will be excluded from enrollment if they meet any of the exclusion criteria. 1. Subjects prohibited from both MRI, CT and Ultrasound scans. 2. Subjects with no lesions visible on CT. 3. Pregnant or lactating(i.e., breastfeeding) subjects. 4. Subjects who are biologically male. 5. Subjects with breast cancer who received neoadjuvant chemotherapy or who have metastasized to other organs 6. Subjects whose biopsy pathology results are Invasive lobular carcinoma 7. Subjects deemed unsuitable for the study according to judgment of the investigator

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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.

Breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Ewha Womans University Medical Center

    RECRUITING

    Seoul, Gangseo-gu, 07804, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Jongno-gu, South Korea

  • Yonsei University Health System, Severance Hospital

    RECRUITING

    Seoul, Seodaemun-gu, South Korea

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