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New breast reconstruction material under safety spotlight

NCT ID NCT06555614

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looks at a new material called SC DERM® Recon, used in breast reconstruction surgery after mastectomy for breast cancer. Researchers want to see if it causes fewer short-term problems than similar materials. About 120 women will take part, and the study will track complications for 12 weeks after surgery.

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.

Participants

About 120 people

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

Started

Jun 2024

Expected to finish

Feb 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.

Who is studied

Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.

Ages

19 to 79 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 Prospective Subjects (Test Group): * Female patients aged 19 to 79 years * Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer * Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits Retrospective Medical Record Collection (Control Group): * Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital * Availability of medical records between March 1, 2021, and March 31, 2024 Exclusion Criteria Prospective Subjects (Test Group): \- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments) Retrospective Medical Record Collection (Control Group): \- Patients with no recorded follow-up visits after application of the acellular dermal matrix

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Conditions

The condition(s) this trial relates to.

breast cancer female breast carcinoma

As listed by the trial registrant

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

Breast cancer female Breast reconstruction

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 National University Hospital

    RECRUITING

    Seoul, Seoul, 03080, South Korea

More trials for these conditions

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