REGENERA Implant in Excised Non-Malignant Breast Lesions

NCT04131972 | Completed

• 1 other identifier: Tens-BBC/001/2017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Breast Disease

Keywords

Lumpectomy; Bio-absorbable

Outcome Measures

Primary Outcomes (1)

• Cumulative number of all Serious Adverse Events

  Cumulative number of Serious Adverse Events collected throughout the study and associated with the REGENERA implant device (Adverse Device Effects)

  at 6 months from implantion of the device

Secondary Outcomes (6)

• Measurement of changes in breast appeareance before and after surgery through antropomorphic chest parameters

  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

• Measurement of the reduction of reliability of the currently used diagnostic imaging techniques

  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

• Patient Quality of Life measured through Breast-Q questionnaire

  at 1 month from the implantation of the device (Day 0), 6 months from Day 0 versus 2 weeks before Day 0

• Patient pain measurement through a Visual Analogue Scale

  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 of the Investigator's satisfaction on the implantation procedure, through a Visual Analogue Scale (VAS) and an ad-hoc questionnaire

  implantation satisfaction (VAS + ad-hoc questionnaire) at the implantation of the device (Day 0) and REGENERA performance (VAS) at 6 months from Day 0

Study Arms (1)

Single arm 1

EXPERIMENTAL

Each patient will be planned to perform 7 study visits and at the second visit excision / lumpectomy and REGENERA implant will be performed during the same surgical intervention.

Device: REGENERA

Interventions

REGENERA DEVICE

REGENERA breast implant

Single arm 1

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Inability to undergo MRI or allergy to contrast media
• Systemic infections in active phase
• Immunocompromised patients (HIV)
• Subjects who have participated in another study within the past 3 months
• Patients who received immunosuppressant therapy in the last 3 months
• Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).

Sponsors & Collaborators

• Tensive SRL: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Related Publications (2)

• Mariniello MD, Roncella M, Mazzotta D, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Ghilli M. Scaffold-based breast conserving surgery in patients with non-malignant breast lesions: long-term follow-up of a first-in-human pilot study on the REGENERA biomimetic breast implant. Breast Cancer. 2026 Jan;33(1):111-122. doi: 10.1007/s12282-025-01780-w. Epub 2025 Sep 27.

  PMID: 41014462 DERIVED

• Mariniello MD, Ghilli M, Favati B, Gerges I, Colizzi L, Tamplenizza M, Tocchio A, Martello F, Ghilardi M, Cossu MC, Danti S, Roncella M. Cell-free biomimetic polyurethane-based scaffold for breast reconstruction following non-malignant lesion resection. A first-in-human study. Breast Cancer. 2023 Jul;30(4):559-569. doi: 10.1007/s12282-023-01446-5. Epub 2023 Mar 28.

  PMID: 36977972 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Manuela Roncella, MD

  Azienda Ospedaliero, Universitaria Pisana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: October 18, 2019
• Study Start: November 11, 2019
• Primary Completion: November 27, 2021
• Study Completion: November 27, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)