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New breast reconstruction material shows promise in clinical trial

NCT ID NCT06555692

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, used in breast reconstruction after mastectomy for breast cancer. It compares how well this material works and its safety against other similar products. About 120 women aged 20 to 69 who are having a mastectomy and immediate implant reconstruction will take part. The goal is to see if SC Derm leads to better cosmetic results and fewer complications.

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

Jan 2024

Expected to finish

Sep 2026

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 have undergone total mastectomy due to breast cancer from three primary university hospitals.

Ages

20 to 69 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 69 scheduled for total mastectomy * Patients who are willing to undergo immediate breast reconstruction using implants. Exclusion Criteria: * Patients who have undergone organ transplantation and are currently taking immunosuppressive medication. * Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse. * Patients who have participated in another clinical trial within 120 days prior to screening. * Any other cases where the investigator deems the patient unsuitable for this clinical study.

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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

Contacts and locations

Locations

  • Soon Chun Hyang University Hospital

    Seoul, Seoul, 04401, South Korea

More trials for these conditions

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