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Which breast implant survives radiation best? study seeks answers

NCT ID NCT06747065

Knowledge-focused Sponsor: University Hospital, Basel, Switzerland 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 1,000 women who had breast reconstruction with implants right after mastectomy, followed by radiation therapy. Researchers compared two types of implants—polyurethane-covered and non-polyurethane-covered—to see which had fewer complications like capsular contracture (hardening) or implant loss. The goal is to help surgeons and patients make better choices for reconstruction when radiation is needed.

What this could mean

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

What this could lead to
If successful, this study could help doctors choose the best type of breast implant to reduce complications like scarring and implant loss after radiotherapy.
What could go wrong
This is a retrospective study, meaning it looks back at past data, not a controlled experiment. Results may not prove cause and effect, and individual patient factors could influence outcomes.

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

1,000 people

The number who actually took part.

Started

Dec 2024

Finished

Dec 2025

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.

Who is studied

data will be collected from patient hospital records, including approximately 30 international sites

Ages

18 years and older

Sex

Anyone

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: * Patients with signed General consent or study specific consent form * Patients with confirmed diagnosis of primary or recurrent breast cancer * Patients undergoing nipple - or skin-sparing mastectomy with prepectoral IBBR (all types of implants, with or without mesh, all types of biologic and synthetic mesh, one- or two- stage) in the setting of PMRT (or any type or RT before reconstruction) between 2016 and 2022. * Patients undergoing two-stage IBBR with radiotherapy to the expander before reconstruction with implant. * Patients with recurrent breast cancer after breast conserving surgery and radiotherapy. * Follow up must be at least 2 years after IBBR. * Patients aged 18 and above will be eligible for inclusion. Exclusion Criteria: * Patients who have explicitly refused the further use of their data through a consent declaration. * Patients undergoing subpectoral IBBR or autologous reconstruction as initial type of reconstruction. * No radiotherapy.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema

As listed by the trial registrant

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

Breast cancer Mastectomy; lymphedema

Contacts and locations

Locations

  • University Hospital Basel

    Basel, 4031, Switzerland

More trials for these conditions

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