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

• Status: Completed
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Eva MedTech, Inc.

Criteria

Inclusion Criteria:

• ambulatory and possess all four limbs

• Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration

• Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study

• Weight less than 400 lbs

Exclusion Criteria:

• Women who are pregnant or breast-feeding

• Persons who are allergic to iodine or indocyanine green

• Heart failure, poorly controlled kidney disease (glomerular filtration rate <30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism

• Any circumstance where increased lymphatic or venous return is undesirable