Benign Breast Disease Clinical Trial
Official title:
A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
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.
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: - In replacing the removed tissue - In potential interference with current diagnostic standard of care imaging procedures - On patient's quality of life and satisfaction - On investigator's satisfaction. ;
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