Clinical Research Directory

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

Sponsor: Tensive SRL

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.

Official title: A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up

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