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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.
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.
Benign Breast Disease
Not yet recruiting
Published on BioPortfolio: 2019-10-24T12:49:48-0400
The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respe...
Benign diseases of the breast are common clinical conditions that affect young women. Complaints related to the breast often cause significant discomfort and mental stress. The following s...
This study will analyze blood samples to identify substances that are associated with the development of breast cancer. It will determine if: - Women who are diagnosed with a benign b...
Prolactin is known to play an important role in breast development and differentiation. Thus proliferative breast diseases are good models to unravel PRl / PRLR function in proliferative p...
The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign breast lesion (BBL) under ultrasound (US) guida...
The management of high-risk benign breast disease (BBD) is changing because of improvements in radiological and pathological analysis. We sought to determine the current practice recommendations of br...
Background Most ductal carcinoma in situ (DCIS) lesions are first detected on screening mammograms as calcifications. However, false-positive biopsy rates for calcifications range from 30% to 87%. Imp...
Idiopathic granulomatous mastitis is a rare relapsing benign inflammatory breast disease with unknown etiology. Its clinical features and imaging signs may mimic inflammatory breast cancer or some oth...
Sarcoidosis is an idiopathic multisystemic inflammatory disease that may exceptionally involve the breast and can have imaging features suspicious for benign or malignant lesions. Biopsy should be req...
The objective of our study was to evaluate whether shear wave elastography (SWE) can differentiate benign from malignant microcalcifications of the breast when detected on ultrasound (US). Between Fe...
A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency.
A rare, benign, inflammatory breast disease occurring in premenopausal women shortly after a recent pregnancy. The origin is unknown but it is commonly mistaken for malignancy and sometimes associated with BREAST FEEDING and the use of ORAL CONTRACEPTIVES.
A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.
A condition in which abnormal cells have not spread outside the duct, lobule, or nipple to other tissues of the breast. There are 3 types of breast carcinoma in situ: DUCTAL CARCINOMA IN SITU; LOBULAR CARCINOMA IN SITU; and PAGET DISEASE OF THE NIPPLE
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
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