Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

NARecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

September 29, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

December 30, 2029

Conditions
Mastectomy, SegmentalBreast Neoplasm Malignant Female
Interventions
DEVICE

REGENERA breast implant implantation

"Each patient will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:~* Screening~* Pre-surgery treatment~* Surgery and study device implant~* Post-surgery follow-up"

Trial Locations (3)

15001

RECRUITING

Complejo Hospitalario Universitario A Coruña, A Coruña

20141

RECRUITING

IEO Istituto Europeo di Oncologia, Milan

56126

RECRUITING

A.O.U. Pisana - Ospedale Santa Chiara, Pisa

All Listed Sponsors
lead

Tensive SRL

INDUSTRY