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Can a special implant safely restore breast shape years after surgery?

NCT ID NCT05533099

Disease control Sponsor: Tensive SRL 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study follows women who received a REGENERA implant after having a non-cancerous breast lump removed. The goal is to see if the implant remains safe and performs well up to five years after the initial surgery. Researchers are tracking any side effects or complications linked to the device.

What this could mean

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

Active substance
REGENERA implant
What this could lead to
If safe and effective long-term, this implant could offer a minimally invasive option for breast shape restoration after surgery for non-cancerous lesions.
What could go wrong
This is a small, early follow-up study with only 14 participants, so results may not apply widely. Long-term safety data are still being collected.

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

14 people

The number who actually took part.

Started

Jul 2021

Finished

May 2026

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 adult subjects diagnosed with localized, non-malignant breast lesions, who underwent surgery with REGENERA implant after excision or lumpectomy of breast tissue, according to protocol Tens-BBC/001/2017

Ages

20 to 85 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: * Patients treated with REGENERA according to protocol Tens-BBC/001/2017 * Patients able and willing to give written informed consent form Exclusion Criteria: \- There are no formal exclusion criteria for participation, as this LTFU study aims at following all the patients who have completed protocol Tens-BBC/001/2017, subject to informed consent.

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Conditions

The condition(s) this trial relates to.

breast benign neoplasm breast disorder

As listed by the trial registrant

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

Breast diseases

Contacts and locations

Locations

  • Unità Operativa di Senologia (Breast Surgery Unit), Ospedale Santa Chiara

    Pisa, Pisa, 56100, Italy

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