JPRN-jRCT2031190064进行中（未招募）3 期
A single-arm, open-label clinical trial to assess the efficacy and safety of the diagnosis/treatment of lymphedema by ICG fluorescent lymphangiography in patients with secondary lymphedema (Phase 3) - A multicenter, collaborative, single-arm, open-label, confirmatory study
Akita Shinsuke0 个研究点目标入组 50 人开始时间: 2019年7月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion criteria (1)
- •A patient who meets all of the following conditions should be subject to the primary registration: A patient who meets all of the following conditions should be subject to the primary registration
- •1)Who was diagnosed with secondary lymphedema of the extremities
- •2)Who was diagnosed with lymphedema of stage I to II lymphedema as defined by the
- •International Society of Lymphology;
- •3)Who was 20 years or older in age at the time of giving consent; and
- •4)Who gave his/her free will-based written informed consent after receiving a sufficient explanation prior to enrollment in the present clinical trial and based on a sufficient understating
- •Inclusion criteria (2)
- •A patient, who meets all of the following conditions, should be subject to the secondary registration:
- •1)In whom the site of linear pattern was confirmed by ICG fluorescent lymphangiography after the primary registration; and
- •2)Who was diagnosed with lymphedema by 99mTc lymphoscintigraphy after the primary registration
排除标准
- •Exclusion criteria (1)
- •A patient who falls under any of the following conditions should not be subject to the primary registration
- •1)Who has primary lymphedema
- •2)Who has allergy against iodine
- •3)Who has shown shock caused by ICG administration in the past
- •4)Who has shown symptoms of allergy caused by 99mTc administration in the past
- •5) Who has a history of hypersensitivity to xylocaine component or amide type local anesthetic.
- •6)Who is lean (BMI 18 kg/m2) or obese (BMI 30 kg/m2)
- •7)Who is a woman being pregnant, being breast-feeding, or willing to become pregnant during the trial period
- •8)Who was otherwise considered inappropriate for enrollment in the clinical trial by the investigator (subinvestigator) , or
- •9)Who has lymphedema in both the upper and lower extremities, thus not allowing limitation to either the upper or lower extremities
- •Exclusion criteria (2)
- •1)A patient, whose ICG fluorescent lymphangiogram falls under any of the following conditions, should not be subject to the secondary registration:
- •(1)In whom the linear pattern cannot be confirmed because of presenting only the area of dermal back flow pattern that is indicative of the reversed current of the collecting lymphatic vessels into the skin and the area where a fluorescent lymphangiogram is not found at all, which led to the judgment that the lymphatic vesels are difficult to identify.
- •(2)Who was otherwise judged to be inappropriate as a subject to the present trial;
- •2)Who has had symptoms of allergy caused by the subcutaneous injection of ICG; or
- •3)Who was diagnosed to have edema due to causes other than lymphedema because of presenting normal lymphoscintigraphic findings.
研究者
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