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

NCT05946837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-12-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Eva MedTech, Inc.

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Melissa B Aldrich, PhD, MBA · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946837 on ClinicalTrials.gov