Status: Recruiting
Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
The goals of this clinical trial are: * demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions * demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.
Participants needed: 92
Trial details
Age: 40-70Biological sex: FemaleType: InterventionalSponsor: Tensive SRLUpdated: Nov 22, 2024Locations: 3
Eligibility criteria
Female adult subject aged 40-70 years. [+11]
Subject with actual concomitant benign breast lesion (B2 and B3), unless present... [+19]