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The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
Full description
This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.
The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.
The secondary objectives of this study are:
To assess the safety of the implant procedure
To assess the feasibility of the implant procedure
To evaluate the performance of REGENERA breast implant:
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15 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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