"PRO-Pocket" - International Prospective Multicenter Post Market Clinical Follow Up to "Patient Reported Outcome" in Primary or Secondary Breast Reconstruction After Mastectomy Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 12
- 主要终点
- Quality of Life - Patient reported outcome
研究概览
简要总结
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra Pocket)
详细描述
This international, multicentre, non-randomised, observational clinical device investigation will be performed to obtain post market information on TiLOOP® Bra Pocket surgical meshes for a period of up to two years. In particular, on patient reported satisfaction (BreastQTM), cosmetic outcome and the rate of complications.
The objective of the clinical Investigation is to establish the efficacy and safety of the TiLOOP® Bra Pocket.
The Investigation will be performed in ten clinical centres in Germany and Austria.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age [≥ 18]
- •Indications of breast reconstruction: histologically confirmed breast cancer, precancerous lesions (DCIS, LCIS), mutation carrier with increased breast cancer risk, strong family history (lifetime risk > 15%)
- •The patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1)
- •Patient information has been provided and all written consents of the patient are available
排除标准
- •Metastatic breast cancer
- •Patient with known contraindications against mesh-assisted or plastic-reconstructive breast surgery according to the instruction for use
- •Patient is kept in an institution under judicial or official orders (MPG §20.3)
- •Participate in another operative clinical trial, if it relates to the area of reconstructive breast surgery and/or influences the primary endpoint of the clinical trial
结局指标
主要结局
Quality of Life - Patient reported outcome
时间窗: 12 months after study treatment
The primary endpoint is defined as the change of the four BreastQ domain scores before study treatment compared to twelve months after study treatment. The BreastQ questionnaire yields a domain score in the range from zero to 100. Wheras a score of 100 is the best score. The study hypothesis is that the patient's QoL after the study intervention treatment is not worse than the QoL prior to the intervention study treatment . The following four domains are relavant: Satisfaction with breasts, Psychosocial well-being, Physical well-being:chest and Sexual well-being.
次要结局
- Quality of Life - Patient reported outcome(6 and 24 months after study treatment)
- Complication rate(6, 12 and 24 months after study treatment)
- Cosmetic outcome(6, 12 and 24 months after study treatment)