Phase IV, Multicenter, Open Label, Non Randomized Comparative Group Study to Assess the Safety and Performance of the OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation Following Breast Reconstruction Post Mastectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
研究概览
简要总结
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.
详细描述
The device has the CE Mark and will be used in the indication for which it is approved.
Up to 60 patients will be assigned to the study (up to 30 patients for Orbix procedure, and up to 30 patients without Orbix procedure (only routine reduction/symmetrisation). Patients will return to the clinic for follow-up at 1, 3, 6, 12 & 24 months (last visit will be optional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any study specific tests or procedures are done.
- •Female subject between the age of 20 and 65 years old
- •Underwent breast reconstruction following unilateral mastectomy and referred to contra lateral symmetrisation procedure that requires reduction of at least 150gr (clarification: the procedure of reconstruction and symmetrisation may be performed simultaneously).
- •Breast size ≥D
排除标准
- •Pregnant or lactating woman.
- •Subject with history of surgical procedures involving the ribs and rib cage.
- •Subject with documented osteoporosis (bone density per DEXA of less than -1.8).
- •Subject with breast implants.
- •Subject is suffering from breast carcinoma or residual malignant tumor in the side of symmetrisation.
- •Subject suffering from reconstruction failure, skin necrosis or implant infection.
- •Subject with diagnosed or suspected auto-immune disease.
- •Subject with pathologies that affect blood coagulation, immune system or any treatment interfering with them.
- •Subject with lesions due to radiation, ulceration, vascular anomalies or history of circulatory disorder.
- •Subject suffering from a progressive fibrocystic disease, considered to be pre-cancerous, without mastectomy.
- •Subject with concurrent diseases determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications such as obesity, smoking, diabetes, autoimmune disease, coagulopathy, chronic lung or severe cardiovascular disease.
- •Use of drugs that might result in high surgical risk and/or significant postoperative complication, including drugs that would interfere with blood clotting.
- •Psychological instability, inappropriate attitude or motivation.
- •Subject participating or that has participated until one month prior to planned procedure, in another investigational study.
结局指标
主要结局
Evaluate the long term performance OrbiSymm by measuring the stability of the symmetrisation before and after the procedure and during the follow up period.
时间窗: up to 24 months
Stability of symmetrisation as measured by comparison of patients' breast measurements before the procedure and during the FU period (measures will be taken by the surgeon in cm)
次要结局
- Evaluate the performance OrbiSymm(up to 24 months)
- Patient satisfaction(up to 24 months)
- Evaluate the long term safety of OrbiSymm(up to 24 months)