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

NCT05946837 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: HSC-MS-23-0093
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Neck Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged

  Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment

Secondary Outcomes (1)

• Change in pain as assessed by the Visual Analog Scale (VAS)

  Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion

Study Arms (1)

Pneumatic Compression Therapy (PCT)

EXPERIMENTAL

Drug: Indocyanine green (ICG) dye; Device: NIRF-LI imaging; Device: Neuroglide pad

Interventions

Indocyanine green (ICG) dye DRUG

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.

Pneumatic Compression Therapy (PCT)

NIRF-LI imaging DEVICE

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

Pneumatic Compression Therapy (PCT)

Neuroglide pad DEVICE

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.

Pneumatic Compression Therapy (PCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eva MedTech, Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neck Pain; Back Pain

Interventions

Indocyanine Green; Coloring Agents

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Melissa B Aldrich, PhD, MBA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 14, 2023
• Study Start: August 29, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)