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3D-Printed mesh aims to improve breast reconstruction outcomes

NCT ID NCT07365267

Disease control Sponsor: Xijing Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new 3D-printed biodegradable mesh used with a silicone implant for immediate breast reconstruction after mastectomy in women with breast cancer. The goal is to see if the mesh improves cosmetic results, patient satisfaction, and safety. The trial will enroll 25 women at one hospital and follow them for outcomes like satisfaction and recurrence.

What this could mean

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

Active substance
3D-printed biodegradable biological mesh
What this could lead to
If successful, this mesh could improve cosmetic results and quality of life for women undergoing immediate breast reconstruction after mastectomy.
What could go wrong
This is a small, early-stage trial with only 25 participants at one center, so results may not apply broadly. Risks include infection, implant issues, or mesh-related 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.

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 25 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

Dec 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

18 to 70 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 breast cancer patients aged 18 to 70 years. * Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines. * Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction. * ECOG performance status of 0-1. * Voluntary participation in the study and signing of the written informed consent form. Exclusion Criteria: * Age \>70 years. * Metastatic breast cancer (Stage IV) at initial diagnosis. * Multicentric, extensive, diffuse lesions, or inflammatory breast cancer. * Tumor involvement of the nipple-areolar complex. * Breast cancer during pregnancy. * History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer. * Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery. * Patients deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

3D-printed biodegradable biological mesh Breast cancer Breast reconstruction after mastectomy

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

  • the First Affiliated Hospital of the Air Force Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

More trials for these conditions

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