Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
FEMALE
NCT05941299

Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Led by Tensive SRL · Updated on 2024-11-22

92

Participants Needed

3

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Who Can Participate

Age: 40Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adult aged 40 to 70 years
  • Diagnosed with malignant breast lesion: monolateral nodular infiltrative carcinoma without microcalcification, single or multifocal within an area up to 4 cm in diameter
  • Non-metastatic (M0) breast cancer
  • Clinically negative axilla
  • Eligible for conservative breast surgery (lumpectomy or quadrantectomy) with volume deficit suitable for REGENERA implant of 70 ml or 100 ml
  • Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no biopsy and imaging discordance
  • Adequate blood and bone marrow function
  • Good general health and mentally sound
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Presence of actual benign breast lesions (B2 and B3) outside the same mammary quadrant or contralateral breast
  • Presence of other malignancies including lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease
  • Planned axillary dissection as part of surgery
  • History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast being studied
  • Skin retraction at the breast to be operated
  • Confirmed infection at surgical site before surgery
  • Abnormal blood sugar or glycosylated hemoglobin levels
  • Smoking more than 10 cigarettes a day
  • Severe acute or chronic kidney failure
  • History of severe asthma or allergies including to anesthetics or contrast media
  • Autoimmune disease
  • Known carrier of BRCA mutation
  • Unable to undergo MRI or allergic to contrast media
  • Active systemic infections
  • Immunocompromised status (HIV)
  • Pregnant, breastfeeding, or nursed a child within 3 months prior to enrollment
  • Participation in another interventional study within past 3 months
  • Use of immunosuppressant therapy in last 3 months
  • History of substance abuse
  • Severe physical disabilities or psychiatric disorders making participation unlikely

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

IEO Istituto Europeo di Oncologia

Milan, Italy, 20141

Actively Recruiting

2

A.O.U. Pisana - Ospedale Santa Chiara

Pisa, Italy, 56126

Actively Recruiting

3

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15001

Actively Recruiting

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Research Team

M

Margherita Tamplenizza

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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