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Can a new implant rebuild the breast right after lumpectomy?

NCT ID NCT05941299

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

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests a new breast implant called REGENERA in women aged 40–70 who are having a lumpectomy for early-stage breast cancer. The implant is placed during the same surgery to fill the gap left by the removed tumor. The study aims to see if the implant is safe and whether surgeons find it easy to use, while also checking that it does not interfere with standard breast cancer imaging like mammograms.

What this could mean

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

Active substance
a breast implant called REGENERA, made from a regenerative material, placed during lumpectomy surgery
What this could lead to
If safe and effective, REGENERA could offer a new option for breast reconstruction immediately after lumpectomy, potentially improving cosmetic outcomes without interfering with cancer follow-up imaging.
What could go wrong
This is an early-stage device trial with only 92 participants, so results may not apply to all patients. Risks include implant-related complications such as infection, implant failure, or interference with cancer surveillance.

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 cancer

As listed by the trial registrant

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

BREAST NEOPLASM MALIGNANT FEMALE MASTECTOMY, SEGMENTAL

Contacts and locations

Locations

  • A.O.U. Pisana - Ospedale Santa Chiara

    Pisa, 56126, Italy

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15001, Spain

  • ICS Maugeri IRCCS

    Pavia, 27100, Italy

  • IEO Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • IRCCS Humanitas Istituto Clinico Catanese

    Catania, 95045, Italy

  • IRCCS Humanitas Research Hospital

    Rozzano, Milano, 20089, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Istituto Oncologico di Candiolo FPO-IRCCS

    Torino, 10060, Italy

  • Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

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