EUCTR2016-005186-31-DK进行中（未招募）1 期
Fat Grafting with Ex-Vivo Expanded Adipose-Derived Stem Cells for Breast Reconstruction Following Mastectomy
Department of Plastic Surgery, Breast and Burns Treatment0 个研究点目标入组 10 人开始时间: 2017年6月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Age 25 - 45 years (25 and 45 included)
- •2.Females who are offered prophylactic, bilateral nipple-sparring mastectomy due to an estimated familial predisposition to develop breast cancer.
- •3.Patients who are deemed fit for breast reconstruction with fat grafting by a plastic surgeon in terms of available fat supply, breast symmetry and small, non-ptotic breast mound.
- •4.Signed informed consent by the patient
- •5.Mutual agreement on acceptable breast volume for point of complete reconstruction between patient and surgeon.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Smoking.
- •2.Diabetes or other comorbidities that may increase the risk of surgical complications assessed by the surgeon.
- •3.Genetic syndromes associated with high risk of cancers other than breast- and ovarian cancer.
- •4.Previous- or planned radiotherapy.
- •5.Asymmetry of the breasts or thorax.
- •6.Pacemaker or other implanted foreign objects in the vicinity of the breast.
研究者
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