Milky Way Sensor: Device Validation for Infiltrated Tissues
ivWatch, LLC
Summary
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 18 years of age or older * Healthy, verified by an eligible designation on the Health History Form Exclusion Criteria: * Abnormal bleeding / hemophilia * Absence of sensation in one or both arms * Allergy to common medical materials * Blood clotting disorder * Currently enrolled in another clinical trial * Current hepatitis infection or any history of hepatitis B or C * Currently pregnant * Daily regimen of blood thinning medication (e.g., aspirin, ibuprofen, naproxen, Coumadin®/warfarin, Eliquis®/apixaban). * Fever at the time of study visit (≥100.4°F) * Frequent dizz…
Interventions
- DeviceivWatch Model 400 with Milky Way Sensor
The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Location
- ivWatchNewport News, Virginia