Status:
COMPLETED
Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function
Lead Sponsor:
Nicole Lindenblatt
Collaborating Sponsors:
Swiss Federal Institute of Technology
Zurich University of Applied Sciences
Conditions:
Lymphedema
Secondary Lymphedema
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Lymphedema is the consequence of injured lymphatic system and is characterized by chronic, often disabling swelling of am affected body part, often arm or leg. In the western world secondary lymphedem...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04393168
Start Date
May 22 2020
End Date
June 26 2020
Last Update
July 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hostpial Zurich
Zurich, Switzerland, 8091