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| Name | Class |
|---|---|
| Eva MedTech, Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumatic Compression Therapy (PCT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa B Aldrich, PhD, MBA | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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|
| 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 |
|
| 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. |
|
| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D004396 | Coloring Agents |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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