Milky Way Sensor: Device Validation for Infiltrated Tissues

Milky Way Sensor: Device Validation for Infiltrated Tissues

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.

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 dizziness or fainting spells, especially with needles
• History of chronic, severe anemia
• History of stroke
• HIV / Aids
• Immune deficiency disorder
• Lymphedema
• Major surgery or scar tissue which would complicate PIV access
• Needle phobia
• Radiation / chemotherapy in the last year
• Received IV therapy in 14 days prior to study visit
• Severe dehydration on day of study visit
• Sick or had an infection in 14 days prior to study visit
• Tattoo(s) that severely limits vein visualization at a sensor monitoring location
• Unstable or uncontrolled cardiopulmonary disorder
• Uncontrolled seizures