REGENERA Implant in Excised Non-Malignant Breast Lesions (NCT04131972) | Clinical Trial Compass
CompletedNot Applicable
REGENERA Implant in Excised Non-Malignant Breast Lesions
Italy15 participantsStarted 2019-11-11
Plain-language summary
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
Who can participate
Age range20 Years – 85 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female patients aged 20-85 years
✓. Patients eligible for excision or lumpectomy, as per current surgical guidelines
✓. Volume deficit compatible with an implant volume of 70 cc
✓. Adequate hematopoietic functions
✓. Good general health and mentally sound
✓. Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
✓. Patients able and willing to give written informed consent form
Exclusion criteria
✕. Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
✕. Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
✕. Infection of the surgical site confirmed pre-operatively by clinical examination
✕. Acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/L)
✕. History of severe asthma or allergies (including to anaesthetics or contrast media)
✕. Autoimmune disease
✕
What they're measuring
1
Cumulative number of all Serious Adverse Events
Timeframe: at 6 months from implantion of the device
. Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
✕. Subject who are known to be carriers of BCRA mutation