NCT01216319已完成不适用
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
研究概览
简要总结
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.
- •Patient presents with a desire to obtain nipple reconstruction
- •Patient is at least 18 years of age
- •And other inclusion criteria
排除标准
- •Patient is not medically fit enough for surgery under local anesthesia
- •Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)
- •Patient is pregnant, breastfeeding or planning further pregnancy during the study period
- •Patient has physical allergies or cultural objections to the receipt of porcine products
- •And other exclusion criteria
结局指标
主要结局
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
时间窗: 12 months
次要结局
- Rate of Patient Satisfaction(12 months)
研究者
研究点 (8)
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