NCT01885572已完成不适用
National, Multicenter Post-market Surveillance Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With Titaniferously Coated Polypropylene Mesh (TiLOOP Bra)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 15
- 主要终点
- PRO
研究概览
简要总结
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well as on the rate of complications of the device under investigation.
The objective of this clinical investigation is to establish the feasibility, efficacy and safety of the TiLOOP® Bra.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The TiLOOP®Bra is designed to assist oncologically indexed skin sparing mastectomy or subcutaneous mastectomy with preservation of the nipple-areola-complex during primary breast reconstruction, secondary breast reconstruction or corrective breast surgery. Patients shall be included if they meet all of the following criteria:
- •Clinical Criteria (reason):
- •women with indication of prophylactic operation or oncoplastic operation with support of a mesh implant
- •women with histologically confirmed breast cancer or precancerosis or genetic pre-existing conditions with increased risk of breast cancer or with a family history
- •the health of women must comply with ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- •Study-related inclusion criteria - Legal reasons:
- •Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
- •Patient information has been handed out and all written consents are at hand.
- •Patient is between 18 and 70 years old.
排除标准
- •Patients must be excluded if any of the following conditions exist or cannot be excluded:
- •Device-related exclusion criteria (contraindications):
- •Pathological or physical condition precluding such as:
- •Pregnancy or breast-feeding patients
- •Known intolerance to the mesh-implants under investigation.
- •Study-related exclusion criteria - Medical reasons:
- •metastatic breast cancer
- •medicamentous regulated diabetes with blood sugar level >250
- •inadequate bone marrow function with neutrophil granulocytes <1500 and blood plates < 10000/µl
- •patient with known contraindication to mesh-implants or plastic-reconstructive breast operations
- •Study-related exclusion criteria - Legal reasons:
- •Lack of written patients informed consent.
- •Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- •Patient is institutionalized by court or official order (MPG§20.3).
- •Participation in another operative clinical investigation.
- •It is thought that the study-related exclusion criteria will not significantly influence the sample of the population under investigation.
结局指标
主要结局
PRO
时间窗: 12 months after breast reconstruction
Measurement of the Patient Reported Outcome (PRO).
次要结局
- PRO and Complication Rate(48 months after breast reconstruction)
- Complication Rate(after 6, 12 and 24 months)
- Cosmetic Success(6, 12 and 24 months after breast reconstruction)
- PRO(6 and 24 months after breast reconstruction)
研究者
研究点 (15)
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