Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-70
SponsorTensive SRL
About this trial
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.
Eligibility criteria
Qualifiers
Female adult subject aged 40-70 years.
monolateral nodular infiltrative carcinoma,
without microcalcification,
single or multifocal,
Disqualifiers
Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
Axillary dissection planned as part of the breast lesion surgery.
History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
Trial design
Treatments tested in this trial
- REGENERA breast implant implantation
Treatment groups
92 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov