NCT05941299进行中（未招募）不适用
A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tensive SRL
- 入组人数
- 92
- 试验地点
- 12
- 主要终点
- Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.
研究概览
简要总结
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.
详细描述
Participants 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 up to 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult subject aged 40-70 years.
- •Subject diagnosed with malignant breast lesion:
- •monolateral nodular infiltrative carcinoma,
- •without microcalcification,
- •single or multifocal,
- •included in an area with a maximum diameter of 4 cm,
- •non-metastatic (M0).
- •Subject with clinically negative axilla.
- •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.
- •Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.
- •Adequate hematopoietic functions.
- •Good general health and mentally sound.
- •Subject able and willing to give written informed consent form.
排除标准
- •Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
- •Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
- •Axillary dissection planned as part of the breast lesion surgery.
- •History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
- •Skin retraction at the breast to be operated.
- •Infection of the surgical site confirmed pre-operatively by clinical examination.
- •Abnormal blood sugar and glycosylated hemoglobin.
- •Hard smoker (more than 10 cigarettes a day).
- •Acute or chronic severe renal insufficiency (creatinine values >180 μmol/l).
- •History of severe asthma or allergies (including allergy to anesthetics or contrast media).
- •Autoimmune disease.
- •Subjects who are known to be carriers of BCRA mutation.
- •Inability to undergo MRI or allergy to contrast media.
- •Systemic infections in an active phase.
- •Immunocompromised patients (HIV).
- •Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
- •Subject who has participated in another interventional study within the past 3 months.
- •Subject who received immunosuppressant therapy in the last 3 months.
- •History of substance abuse (drug or alcohol).
- •Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).
研究组 & 干预措施
REGENERA breast implant implantation
Experimental
Single monolateral breast implant
干预措施: REGENERA breast implant implantation (Device)
结局指标
主要结局
Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months.
时间窗: 3 months
The rate of AEs with a causal relationship to REGENERA should be \<5% at 3 months after implant.
次要结局
- Mean investigator's satisfaction on REGENERA usability during surgery at 1 week.(1 week after implant)
- Mean investigator's satisfaction on the implanting procedure at 1week.(1 week after implant)
- Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators.(After 6 and 12 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)
- Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months.(12 months)
- Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators.(After 12 months)
- 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)
- 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)
研究者
研究点 (12)
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