NCT02020837终止早期 1 期
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
研究概览
简要总结
This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18-70 years of age
- •Subject is Stage II-IV unilateral lymphedema
排除标准
- •Subject is less than 6 months from completion of cancer treatment
- •Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
- •Subject is medically unfit for the procedure
- •Subject is unable to complete the follow-up visits
- •Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
- •Subject has bilateral lymphedema
研究组 & 干预措施
Lymphaticovenous Micro-Anastomosis
Experimental
干预措施: Lymphaticovenous Micro-Anastomosis (Procedure)
结局指标
主要结局
Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
时间窗: 3 and 6 months from surgery
Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.
次要结局
未报告次要终点
研究者
研究点 (2)
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