Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT04393168
Eligibility Criteria:
Inclusion criteria:
* informed consent as documented by signature
* females and males 18 - 75 years old,
* established (stage 2 or higher) unilateral secondary arm or leg lymphedema resulting from lymphadectonomy, radiation or any other surgical treatment, infection or injury.
* good general health status.
Exclusion criteria:
* critical illness (active cancer, renal failure, hepatic dysfunction)
* active infection
* blood vascular malformations or diseases
* scleroderma
* primary lymphedema
* patients who underwent any surgical procedures for treatment of lymphedema (e.g. lymphovenous anastomosis, liposuction, lymph node transfer).
* contraindications to use ICG (VERDYE), i.e.
* patients with hypersensitivity to ICG or to sodium iodide
* patients with hypersensitivity to iodine,
* patients with hyper-thyroidism, patients with autonomic thyroid adenomas
* patients in which the injection of VERDYE was poorly tolerated in the past it must not be used again, since severe anaphylactic reactions might occur.
* hypersensitivity to albumin or its excipients
* women, who are pregnant (pregnancy test will be performed in case of women who did not undergo menopause),
* women who are breast feeding ,
* enrolment of the investigator, his/her family members, employees and other dependent persons,
* known or suspected non-compliance, drug or alcohol abuse,
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* participation in another study with investigational drug within the 30 days preceding and during the present study,
* previous enrolment into the current study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04393168
Study Brief:
Protocol Section:
NCT04393168