Back to resultsNear-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Primary Purpose
Neck Pain, Back Pain
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine green (ICG) dye
NIRF-LI imaging
Neuroglide pad
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility 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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pneumatic Compression Therapy (PCT)
Arm Description
Outcomes
Primary Outcome Measures
Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged
Secondary Outcome Measures
Change in pain as assessed by the Visual Analog Scale (VAS)
This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain
Full Information
NCT ID
NCT05946837
First Posted
June 29, 2023
Last Updated
July 7, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eva MedTech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05946837
Brief Title
Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Official Title
Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 29, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eva MedTech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pneumatic Compression Therapy (PCT)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine green (ICG) dye
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NIRF-LI imaging
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Neuroglide pad
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged
Time Frame
Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment
Secondary Outcome Measure Information:
Title
Change in pain as assessed by the Visual Analog Scale (VAS)
Description
This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain
Time Frame
Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa B Aldrich, PhD, MBA
Phone
713-500-3565
Email
Melissa.B.Aldrich@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Rasmussen
Phone
713-500-3393
Email
John.Rasmussen@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa B Aldrich, PhD, MBA
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
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