Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device

PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 29, 2023

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

Conditions
Neck PainBack Pain
Interventions
DRUG

Indocyanine green (ICG) dye

ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.

DEVICE

NIRF-LI imaging

Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment

DEVICE

Neuroglide pad

After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

Eva MedTech, Inc.

UNKNOWN

lead

The University of Texas Health Science Center, Houston

OTHER

NCT05946837 - Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device | Biotech Hunter | Biotech Hunter