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 sites50 target enrollmentJuly 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

July 30, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Akita Shinsuke

•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

•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