Multicenter Study of TCD-10214 for Secondary Lymphedema (Feasibility Study)

Hayashi Shoko0 个研究点目标入组 20 人开始时间: 2022年12月8日最近更新: 2024年4月23日

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

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: >= 18age old 至 <= 75age old（—）
性别: Female

入选标准

•(1)At least 18 years old but less than 75 years old at the time of signing the informed consent form.
•(3)Having a diagnosis of secondary lymphedema in the ipsilateral upper limb after surgery for malignant mammary gland tumor with axillary lymph node dissection.
•(4)Stage I or II (excluding late stage II) according to the ISL classification.
•(5)Eastern Cooperative Oncology Group performance status (PS) of 0 to 2.
•(6)Dermal backflow patterns in the affected upper arm or forearm identified by indocyanine green (ICG) fluorescence lymphangiography.
•(7)Target sites of investigational devices can be secured both distal and proximal to the dermal backflow area by ICG fluorescence lymphangiography of the affected limb.
•(8)No improvement in lymphedema in spite of receiving compression therapy using a compression garment without changing the pressure on the affected limb for at least 30 days before the time of informed consent, and the therapy is planned to continue without any change in the pressure for at least 36 days after the investigational implantation. The pressure of the compression garment should be 15 to 40 mmHg.
•(9)An >=10% increase in volume of the affected limb compared to that of the unaffected limb as calculated from the circumference measurements, or an >=1.0cm increase in circumference measurements of affected limb compared to that of the unaffected limb at least one mesurement location. Each comparison shoud be made at the same distance from the measurement starting point.
•(10)Voluntary written informed consent from the subject themselves after understanding the contents of the written information.
•(11)Be willing and able to comply with the protocol requirements, such as the visit schedule.

排除标准

•(1)Past history of the invasive treatment of lymphedema of the affected limb such as lymphovenous anastomosis (LVA), vascularized lymph node transfer (VLNT), liposuction, debulking surgery, intra-arterial infusion of autologous lymphocytes, lymph vessel transplantation, flap transfer, and adipose stem cell transplantation or being scheduled for such treatment within 12 months of the investigational device implantation
•(2)Past history of multilayer bandaging for the treatment of lymphedema of the affected limb within 3 months after informed consent date or being scheduled for such treatment within 12 months of the investigational device implantation
•(3)Within 365 days of either the date of breast adenocarcinoma (including recurrence) surgery or completion of cancer radiation therapy, whichever comes late.
•(4)Either use of cancer drug therapy except for endocrine therapy, or within 180 days after the completion of cancer drug therapy except for endocrine therapy.
•(5)Past diagnosis of primary lymphedema or having a diagnosis of lymphedema in a site other than the affected limb.
•(6)Evidence of other edematous diseases, such as deep vein thrombosis, varicose veins, hypoalbuminemia, thyroid disease, cardiogenic disease, endocrine disease, or drug induced disease at the time of informed consent.
•(7)Body mass index (BMI) >=30
•(8)Past diagnosis of breast cancer in the contralateral side of the affected limb.
•(9)Use of immunosuppressive drugs, including steroids, within 30 days of projected implantation date.
•(10)Use of diuretics, Gorei-san, Sairei-to, and/or Gosha-jinki-gan that are intened to improve symptoms of edema within 30 days of projected implantation date.
•(11)Known history of hypersensitivity to collagen
•(12)Known history of hypersensitivity to contrast media (indocyanine green or technetium [99mTc]-human serum albumin diethylenetriamine pentaacetic acid injection in the Minimum Requirements for Radiopharmaceuticals).
•(13)Lymphorrhea, lymphocyst, cellulitis, or obvious skin sclerosis at the time of informed consent.
•(14)Malignancies at the time of informed consent.
•(15)Pregnant, lactating, may be pregnant, or having a plan to become pregnant during participation in the study.
•(16)Medical conditions deemed by the principal investigator or subinvestigator to jeopardize the evaluation of efficacy or safety
•(17)Being currently participating in another clinical study at the time of informed consent in which the evaluation of the primary endpoint has not been completed yet or which clinically impedes evaluations in this study

研究者

发起方

Hayashi Shoko

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