Clinical trial NCT04131972: REGENERA Implant in Excised Non-Malignant Breast Lesions
Official title: A Pilot Study of REGENERA Implant in Localized Non- Malignant Breast Lesions Treated by Excision or Lumpectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Breast Disease
Keywords: Lumpectomy
Bio-absorbable
Lead sponsor: Tensive SRL
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This is a pre-market, single center, interventional, open label, non-comparative, pilot first-in-human study on adult female patients with localized non-malignant breast lesion. This study will include an enrollment period of 12 months and 6 months study duration per patient.

The primary objective of this study is to demonstrate the safety profile of a new breast implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.

The secondary objectives of this study are:

* To assess the safety of the implant procedure
* To assess the feasibility of the implant procedure
* To evaluate the performance of REGENERA breast implant:

  * In replacing the removed tissue
  * In potential interference with current diagnostic standard of care imaging procedures
  * On patient's quality of life and satisfaction
  * On investigator's satisfaction.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged 20-85 years
2. Patients eligible for excision or lumpectomy, as per current surgical guidelines
3. Volume deficit compatible with an implant volume of 70 cc
4. Adequate hematopoietic functions
5. Good general health and mentally sound
6. Confirmation of non-malignant lesion (B2 and B3) with no discordance between biopsy and radiological imaging
7. Patients able and willing to give written informed consent form

Exclusion Criteria:

1. Pregnant or breastfeeding women or women who have nursed a child three months within enrolment in the study
2. Non-malignant lesions (B2 and B3) with discordance between biopsy and radiological imaging
3. Infection of the surgical site confirmed pre-operatively by clinical examination
4. Acute or chronic severe renal insufficiency (creatinine values \< 180 μmol/L)
5. History of severe asthma or allergies (including to anaesthetics or contrast media)
6. Autoimmune disease
7. Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
8. Subject who are known to be carriers of BCRA mutation
9. Inability to undergo MRI or allergy to contrast media
10. Systemic infections in active phase
11. Immunocompromised patients (HIV)
12. Subjects who have participated in another study within the past 3 months
13. Patients who received immunosuppressant therapy in the last 3 months
14. Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

Primary outcomes:
measure: Cumulative number of all Serious Adverse Events
timeFrame: at 6 months from implantion of the device
Secondary outcomes:
measure: Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters
timeFrame: at 2 weeks before the implantation of the device (Day 0), 1 week from Day 0, 3 months from Day 0, 6 months from Day 0
measure: Measurement of the reduction of reliability of the currently used diagnostic imaging techniques
timeFrame: at 1 week from the implantation of the device (Day 0), 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
measure: Patient Quality of Life measured through Breast-Q questionnaire
timeFrame: at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0
measure: Patient pain measurement through a Visual Analogue Scale
timeFrame: at 2 weeks before the implantation of the device (Day 0), Day 0, 1 week from Day 0, 2 weeks from Day 0, 1 month from Day 0, 3 months from Day 0 and 6 months from Day 0
measure: Measure of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire
timeFrame: implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0
measure: Cumulative number of all Adverse Events associated with the surgical procedure
timeFrame: at 6 months from the implantation of the device
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Manuela Roncella, MD
role: PRINCIPAL_INVESTIGATOR
References: