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

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

June 26, 2020

Study Completion Date

June 26, 2020

Conditions
LymphedemaSecondary Lymphedema
Interventions
COMBINATION_PRODUCT

Lymphatic clearance measurement

The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying attention to the contralateral symmetry of the injections. The signal at the injection sites will be measured over time using a hand-held portable device LymphMeter 1.0 for the total duration of 3 h. In the first hour, the signal will be measured every 15 minutes followed by measurements every half an hour. Immediately after injection (t=0 h), 1.5 h and 3 h after injection the skin area occupied by the tracer will be measured using a standard near-infrared camera, Fluobeam. The dermal reaction at the injection site will be assessed by observations for presence of redness/erythema and measuring its extent according to the needs. The patient will be constantly observed for the signs of allergic reactions, skin irritations or intolerances.

Trial Locations (1)

8091

University Hostpial Zurich, Zurich

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Swiss Federal Institute of Technology

OTHER

collaborator

Zurich University of Applied Sciences

OTHER

collaborator

University Hospital, Zürich

OTHER

collaborator

NanoPass Technologies Ltd

INDUSTRY

lead

Nicole Lindenblatt

OTHER