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New implant aims to make breast cancer surgery look better

NCT ID NCT07345026

Symptom relief Sponsor: Seoul St. Mary's Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special skin-like sheet (SureDerm) placed during breast-conserving surgery can improve how the breast looks and feels afterward. About 116 women with breast cancer will be randomly assigned to get the implant or standard surgery alone. Researchers will track patient satisfaction and complications for one year.

What this could mean

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

Active substance
Acellular dermal matrix (SureDerm BCS)
What this could lead to
If it works, this could improve how the breast looks and feels after cancer surgery, with no increase in complications.
What could go wrong
This is a small, early-stage trial (116 people) that hasn't started yet. The implant may not improve satisfaction and could cause side effects like infection or poor healing.

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 116 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

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

20 to 75 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: * Female patients aged 20 to 75 years * Diagnosed with unilateral breast cancer (ICD-10 code: C50, D05) and treated with breast-conserving surgery * Agreed to the use of acellular dermal matrix (ADM) during surgery * Histologically confirmed primary breast cancer * Patients who received neoadjuvant chemotherapy are eligible * Planned to receive standard postoperative treatment, including adjuvant radiotherapy * Voluntarily decided to participate in the study and provided written informed consent Exclusion Criteria: * Evidence of distant metastasis * Presence of infectious disease, autoimmune disease (e.g., specific rheumatologic disorders), or bleeding/coagulation disorders * Known adverse reactions to all first-line antibiotics * Suspected inflammatory infection of the breast prior to surgery * Pregnant women at the time of enrollment * Definite contraindications to the use of acellular dermal matrix * Contraindications to radiotherapy * Male patients * History of another malignancy diagnosed within the past 5 years * Patients deemed unsuitable for participation due to difficulty in data collection as judged by the investigator * Patients unable to understand or complete the study questionnaires

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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 Mastectomy, segmental

How to take part

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

  1. The places running it

    1 site. 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

  • Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

    Seoul, Seoul, 06591, South Korea

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