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To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
6. Clinical Hypotheses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity. |
| |
| Control group | Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insight Pro Device for Diagnosis | Diagnostic Test | Insight Pro Device for Diagnosis of Lymphatic and Venous Disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Edema Volume | Edema Volume detection by difference in extracellular fluid volume through bioimpedance and dielectric constant measurement. | Acute - At day 0 |
| Fibrosis | Durometer detection or Skin hardness (fibrosis) difference through a durometer measurement. | Acute - At day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/AEs | Safety during use (via adverse event reporting) | Acute - At day 0 |
| LymVAS | Correlation with quality-of-life objective parameters using a lymphedema visual analog scale |
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Inclusion Criteria:
Test group -
Control group -
Exclusion Criteria:
● Inability or unwillingness to participate in all aspects of the study protocol and/or failure to provide informed consent
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(Test Group) - Up to 50 subjects will be enrolled with unilateral or bilateral edema in the upper or lower extremity.
(Control Group) Up to 50 patients will be enrolled from a healthy volunteer group as a control, with no edema.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koya Medical, Inc. | Oakland | California | 94607 | United States |
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| Acute - At day 0 |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
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