Active — Not RecruitingNot Applicable

REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up

Italy14 participantsStarted 2021-07-27

Plain-language summary

In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy. The technique was minimally invasive, easily repeated and associated with minimal surgical morbidity. It is important to assess whether the positive safety and performance results obtained during the initial 6 months post- surgery are maintained in the long-term, for up to 5 years after surgery. In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.

Who can participate

Age range20 Years – 50 Years

SexFEMALE

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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.

What they're measuring

Rate of adverse events

Timeframe: 54 months

Trial details

NCT IDNCT05533099

SponsorTensive SRL

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-05-17

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