A Pilot Study of REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tensive SRL
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Rate of adverse events
研究概览
简要总结
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy. The technique was minimally invasive, easily repeated and associated with minimal surgical morbidity.
It is important to assess whether the positive safety and performance results obtained during the initial 6 months post- surgery are maintained in the long-term, for up to 5 years after surgery.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
详细描述
REGENERA is a polymeric bioresorbable scaffold. The REGENERA matrix is characterized by an interconnected open pore/void structure, having average pore/void diameter from 0.3 to 6.5 mm and local thickness of 30 μm ± 20 μm (μCT 50, SCANCO Medical AG, Brüttisellen, Switzerland). A network of channels is embedded into the porous structure according to a specific pattern, where the channels are interconnected with the porous structure.
The biomaterial constituting REGENERA is composed of a patented biodegradable cross-linked poly(urethane-ester- ether) foam coated with a bio adhesive macromolecule [Poly(L- lysine); PLL] and hydrophobized by Oleic acid (18:1 n-9), a monounsaturated fatty acid.
The shape and geometry of REGENERA have been set to facilitate its insertion to the implantation site and to fulfill the volume deficit caused by excision of lesioned soft tissue after lumpectomy.
REGENERA is a polymeric bioresorbable scaffold intended to support the ingrowth of the patient's soft tissue when used to restore the natural appearance of the breast after surgical removal of benign and malignant breast lesions, up to 200 cc in volume.
In this long-term follow-up study we will assess long-term safety and performance of REGENERA implant after excision or lumpectomy of breast tissue in patients with non-malignant lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients treated with REGENERA according to protocol Tens-BBC/001/2017
- •Patients able and willing to give written informed consent form
排除标准
- •- There are no formal exclusion criteria for participation, as this LTFU study aims at following all the patients who have completed protocol Tens-BBC/001/2017, subject to informed consent.
结局指标
主要结局
Rate of adverse events
时间窗: 54 months
Rate of adverse events associated with the device (REGENERA implant)
次要结局
未报告次要终点