Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Breast Neoplasm Malignant Female Clinical Trial

Official title: A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy

Status Recruiting

Clinical Trial Summary

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 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 up to 5 years

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breast Neoplasm Malignant Female
• Breast Neoplasms
• Mastectomy, Segmental
• Neoplasms

• NCT number: NCT05941299
• Study type: Interventional
• Source: Tensive SRL
• Contact: Margherita Tamplenizza
• Phone: +39 0256660185
• Email: margherita.tamplenizza@tensivemed.com
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Completion date: December 30, 2029