NCT04393168

Proof-of-concept Study of LymphMonitor 1.0 to Assess the Lymphatic Vessel Function

Completed Phase 1 Last updated 14 July 2020

What this trial tests

Phase 1 trial testing Lymphatic clearance measurement in Lymphedema in 10 participants. Completed in 26 June 2020.

Timeline

22 May 2020

Primary endpoint
26 June 2020

26 June 2020

Quick facts

Lead sponsor	Nicole Lindenblatt
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	10
Start date	22 May 2020
Primary completion	26 June 2020
Estimated completion	26 June 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Lymphatic clearance measurement

Conditions studied

• Lymphedema — all drugs for Lymphedema →
• Secondary Lymphedema — all drugs for Secondary Lymphedema →

Sponsor

Nicole Lindenblatt

Who can join

Adults 18 to 75, any sex, with Lymphedema or Secondary Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 lymphedema arises most commonly after removal lymph nodes in an operation as a part of cancer treatment (for example from the armpits or the groin region), however it may also develop as a result of radiation, any other operation, infection or injury that destroys a part of lymphatic system. The disease often develops even years after the event. While there is no cure for lymphedema at present, early detection would ensure timely physiotherapy and application of compression garments that significantly slow down or stop the progression of the disease. However, presently used methods of that are used for diagnosis and evaluating the stage of the disease, are either invasive and expensive or inaccurate and can only be performed at specialized medical centres.

Therefore, we developed a simple, affordable and accurate technology, LymphMonitor 1.0 that can allow for testing how efficiently the lymphatic system is functioning. The test can be performed at the local medical centre or potentially even at home.

In this study, we investigate whether LymphMonitor 1.0 technology can distinguish between a healthy and a diseased lymphatic system (in lymphedema). This method may allow early diagnosis of lymphedema so that the development of the disease can be detected and prevented early enough. By participating in the study the lymphedema patients are making an important contribution to increasing the quality of life of lymphedema patients. In LymphMonitor 1.0 method method, a solution of a safe fluorescent dye, indocyanine green, is injected painlessly using tiny microneedles, MicronJet600TM, directly into the skin of the arm or leg. After injection, this dye is removed from the skin only through the lymphatic vessels. The intensity of the fluorescence signal corresponds to the amount of dye left in the skin. The decrease in the fluorescence signal after the injection is measured on the surface on the skin using a new device, LymphMeter 1.0. The faster the dye (and that fluorescence signal) disappears from the surface of the skin, the better the lymphatic system works. Therefore in the arm or leg affected by lymphedema the fluorescence signal will decrease much slower compared to the healthy one.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Clinical Validation of the LymphMonitor Technology to Quantitatively Assess Lymphatic Function.
   Polomska A, Gousopoulos E, Fehr D, Bachmann A, et al · · 2021 · cited 1× · PMID 34679571 · DOI 10.3390/diagnostics11101873