NCT04051892已完成不适用
A Prospective, Open Label, Single Arm, Multicenter Study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FixNip Ltd
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
A prospective, Open Label, Single arm, Multicenter study Evaluating the FixNip™ NRI Safety and Performance in Female Patients Seeking Reconstructive Surgery of the Nipple.
详细描述
This is a Prospective, Open label, Single arm, Multicenter Study enrolling female patients with a history of breast cancer following breast conservation surgery or mastectomy with breast reconstruction, seeking reconstruction of the breast nipple and areola complex.
The study is designed to evaluate the long-term safety and performance of the FixNip NRI in patients undergoing nipple reconstruction procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 22-70 years.
- •Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study.
- •History of breast cancer post mastectomy with breast implant or partial mastectomy (lumpectomy) of the central segment of the breast seeking reconstruction of the nipple and/or areola complex.
- •At least 3 months post breast reconstruction surgery.
- •Baker scale grade I or II capsular contracture.
- •No evidence of any systemic or chronic disease that might influence wound healing and infection rate.
- •Event free post breast and/or nipple reconstruction procedure, i.e. no skin infections or related infections that mandated antibiotic therapy, no wound dehiscence or any other related medical complications.
- •Pinch test of intended nipple location on affected breast of at least 15 mm.
- •Patient is willing to postpone tattooing until the end of follow-up period.
- •Patient is willing and able to give their written informed consent.
排除标准
- •Active malignant disease.
- •Subject has a chronic disease or any medical status that, according to surgeon discretion, prohibits from inclusion in the study i.e. diabetes.
- •History of tendency to produce hypertrophic scars or keloids.
- •Current use of any medications that can interfere with wound healing, impair the immune system functionality, or impair blood clotting mechanisms.
- •Active infection within the last 30 days.
- •Pregnant or nursing women.
- •Connective tissue disease.
- •'Lupus disease' defined as Systemic Lupus Erythematous or Discoid Lupus, or scleroderma defined as Progressive Systemic Sclerosis per history.
- •Chronically treated with steroids or steroid therapy in a 3month period before surgery.
- •Demonstrate psychological characteristics, which, in the opinion of the Investigator and/or consulting physician(s) are incompatible with the risks, involved with the surgical procedure, prosthesis and compliance with follow-up recommendations.
- •Past or current capsular contracture defined as Baker III or IV.
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
结局指标
主要结局
Adverse event
时间窗: 12 months
Frequency and severity of Adverse Event . All adverse events occurring during the study will be reported
次要结局
- Nipple Projection(12 months)
研究者
研究点 (1)
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