TCD-10214

JRCT ID: jRCT2062220075

Registered date:08/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Secondary Lymphedema
• Date of first enrollment: 08/12/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): A single procedure is performed, which TCD-10214 is implanted in the subcutaneous tissue across the area of normal lymphatic vessel function from distal to proximal to the site of lymphatic vessel dysfunction. The amount of TCD-10214 required for the procedure is determined by the length of the lesion.

Outcome(s)

• Primary Outcome: Presence or absence of lymphangiogenesis at 12 months after surgery (ICG fluorescence lymphangiographic finding)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Female

Include criteria

(1)At least 18 years old but less than 75 years old at the time of signing the informed consent form.
(2)Women.
(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.

Exclude criteria

(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

Related Information

• Primary Sponsor: Hayashi Shoko