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| Name | Class |
|---|---|
| Robert H. Lurie Cancer Center | OTHER |
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The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are:
Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable devices to detect lymphedema | Device | All participants will undergo measurement of the upper extremities to test the validity and safety of wearable sensors to measure lymphedema. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Hydration Score Recorded from the Tissue Hydration Sensor | This score will determine whether or not fluid associated with lymphedema is detected when compared to previously validated measures (bioimpedance spectroscopy and tissue dielectric constant). This is a continuous ratio level of measurement. | From enrollment to the end of the measurement session (appx. 3 hours) |
| Tissue Stiffness Score from the Tissue Stiffness Sensor | This score will determine whether or not tissue affected by lymphedema can yield is detected when compared to a comparable clinical measurement device using Young's Modulus. This is a continuous ratio level of measurement. | From enrollment to the end of the measurement session (appx. 3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioimpedance spectroscopy (BIS) L-Dex score | The bioimpedance spectroscopy L-Dex score is a ratio that represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb. | Three hours |
| Tissue Dielectric Constant (TDC) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will recruit patients using the above specified criteria in the Chicagoland area.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The tissue dielectric constant (TDC) is derived from an electromagnetic wave that is reflected back from transmission into the tissue. It represents free and bound water in the tissue. |
| From enrollment to the end of the measurement session (appx. 3 hours) |
| Volume of the Upper Extremities | Circumferential volumetric measurement is obtained by modeling the limb as a frustum and taking a series of circumferential measurements using anatomical landmarks at predetermined intervals (typically every 4cm), beginning at the wrist and ending at the anterior axillary fold. Volume differences of +10% represents the presence of lymphedema. | Three hours |