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This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Infusion Patients | Experimental | Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-invasive thermal infusion site monitoring NTISM device | Device | Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal skin measurements | Exploratory assessment of thermal skin measurements taken with the study device | Up to 12 hours of monitoring with a 15-minute follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Somera | Contact | 855-814-3569 | clinical@rhaeos.com |
| Name | Affiliation | Role |
|---|---|---|
| R. Chad Webb | Rhaeos, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infusacare | Recruiting | Skokie | Illinois | 60076 | United States |
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