NCT05941299

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Tensive SRL · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Mastectomy, Segmental
• Breast Neoplasm Malignant Female

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-29
• Primary completion: 2025-02-28
• Completion: 2029-12-30
• First posted: 2023-07-12
• Last updated: 2024-11-22

Locations

3 sites across 2 countries: Italy, Spain