NCT04131972

REGENERA Implant in Excised Non-Malignant Breast Lesions

A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tensive SRL · Industry
• Sex: Female
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Benign Breast Disease

Interventions

Type	Name	Description
DEVICE	REGENERA	REGENERA breast implant

Timeline

• Start date: 2019-11-11
• Primary completion: 2021-11-27
• Completion: 2021-11-27
• First posted: 2019-10-18
• Last updated: 2022-02-08

Locations

1 site across 1 country: Italy