jRCT2062220075进行中（未招募）不适用
Multicenter Study of TCD-10214 for Secondary Lymphedema (Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- Presence or absence of lymphangiogenesis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 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
- •(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
结局指标
主要结局
Presence or absence of lymphangiogenesis
时间窗: 12 months after surgery
ICG fluorescence lymphangiographic finding
次要结局
未报告次要终点
研究者
相似试验
暂停
不适用
TCD-11226jRCT2052230047Terumo Corporation42
进行中（未招募）
不适用
TCD-12261jRCT2042230075Terumo Corporation40
招募中
1 期
A study to investigate safety and efficacy with SAR445514 in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light-chain amyloidosis (RRLCA)CTIS2022-502057-33-00Sanofi-Aventis Recherche & Developpement105
进行中（未招募）
1 期
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KD033 (SAR445710) in Subjects With Metastatic or Locally Advanced Solid TumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104CancerCTIS2022-503080-15-00Kadmon Corporation LLC80
进行中（未招募）
1 期
Effects of NT-0796 in Healthy Volunteers and Patients with Parkinson’s DiseaseMedDRA version: 21.1Level: LLTClassification code: 10013113Term: Disease Parkinson's Class: 10029205Parkinson's DiseaseCTIS2023-503203-29-00odthera Limited14