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The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions:
• Does the revised method of compression improve lymph movement and lymphatic propulsion?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced pneumatic compression device (APCD) | Device | Single APCD treatment session at visit 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lymphatic anatomy | • The distance (cm) that lymph travels from injection sites | Before and after 60-minute treatment in clinic with APCD |
| Lymphatic propulsion | • Number of lymph propulsion events per minute | Before and after 60-minute treatment in clinic with APCD |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate swelling in treatment limbs | • Changes in leg circumferential measurements (cm) | Before and after 60-minute treatment in clinic with APCD |
| Evaluate swelling in treatment limbs | Change in local water content (ratio of % water content in legs to reference site) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President Marketing and Market Access | Contact | 1.833.382.2845 | clinicalresearch@tactilemedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth Houston (The University of Texas Health Science Center at Houston) | Recruiting | Houston | Texas | 77030 | United States |
This is a pilot study.
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| Advanced pneumatic compression device (APCD) with revised compression programming | Device | APCD with revised compression programming will be single treatment session at visit 2 |
|
| Indocyanine Green (IC-Green) | Drug | Indocyanine Green dye will be used to assess primary endpoint |
|
| Before and after 60-minute treatment in clinic with APCD |
| Adverse Events | • Adverse Event assessments | Through completion of study at Visit 2, up to 4 weeks |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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