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

NCT ID NCT05533099

Completed Disease control Sponsor: Tensive SRL Source: ClinicalTrials.gov ↗

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.

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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

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Locations

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

Pisa, Pisa, 56100, Italy

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