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
Study Details
Study Description
Brief Summary
The goals of this clinical trial are:
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demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
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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:
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Screening
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Pre-surgery treatment
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Surgery and study device implant
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Post-surgery follow-up up to 5 years
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: REGENERA breast implant implantation
|
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
|
Outcome Measures
Primary Outcome Measures
- Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months. [3 months]
The rate of AEs with a causal relationship to REGENERA should be <5% at 3 months after implant.
Secondary Outcome Measures
- Mean investigator's satisfaction on the implanting procedure at 1week. [1 week after implant]
At least 7 in a 0-10 Visual Analogue Scale, VAS.
- Mean investigator's satisfaction on REGENERA usability during surgery at 1 week. [1 week after implant]
At least 40 in an "ad hoc" questionnaire (12-60 scale).
- Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months. [12 months]
At least 7 in a 0-10 Visual Analogue Scale, VAS.
- Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators. [After 6 and 12 months]
An imaging evaluation questionnaire will be provided for investigators to fill out.
- Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators. [After 12 months]
An imaging evaluation questionnaire will be provided for investigators to fill out.
- Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators. [After 6 and 18 months]
An imaging evaluation questionnaire will be provided for investigators to fill out.
- Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months. [After 3 months and up to 18 months]
The rate of REGENERA-related SAEs should be <5% at each follow-up after 3 months and up to 18 months.
- Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years. [After 18 months and up to 5 years]
The rate of REGENERA-related SAEs should be <7% at each follow-up after 18 months and up to 5 years.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female adult subject aged 40-70 years.
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Subject diagnosed with malignant breast lesion:
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monolateral nodular infiltrative carcinoma,
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without microcalcification,
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single or multifocal,
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included in an area with a maximum diameter of 4 cm,
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non-metastatic (M0).
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Subject with clinically negative axilla.
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Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.
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Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.
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Adequate hematopoietic functions.
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Good general health and mentally sound.
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Subject able and willing to give written informed consent form.
Exclusion Criteria:
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Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
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Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
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Axillary dissection planned as part of the breast lesion surgery.
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History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
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Skin retraction at the breast to be operated.
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Infection of the surgical site confirmed pre-operatively by clinical examination.
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Abnormal blood sugar and glycosylated hemoglobin.
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Hard smoker (more than 10 cigarettes a day).
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Acute or chronic severe renal insufficiency (creatinine values >180 μmol/l).
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History of severe asthma or allergies (including allergy to anesthetics or contrast media).
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Autoimmune disease.
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Subjects who are known to be carriers of BCRA mutation.
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Inability to undergo MRI or allergy to contrast media.
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Systemic infections in an active phase.
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Immunocompromised patients (HIV).
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Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
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Subject who has participated in another interventional study within the past 3 months.
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Subject who received immunosuppressant therapy in the last 3 months.
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History of substance abuse (drug or alcohol).
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Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IEO Istituto Europeo di Oncologia | Milan | Italy | 20141 | |
| 2 | A.O.U. Pisana - Ospedale Santa Chiara | Pisa | Italy | 56126 | |
| 3 | Complejo Hospitalario Universitario A Coruña | A Coruña | Spain | 15001 |
Sponsors and Collaborators
- Tensive SRL
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tens-BBC/003/2021