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REGENERA Implant in Excised Non-Malignant Breast Lesions

2019-10-24 12:49:48 | BioPortfolio

Summary

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.

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:

- 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.

Study Design

Conditions

Benign Breast Disease

Intervention

REGENERA

Status

Not yet recruiting

Source

Tensive SRL

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:48-0400

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