Milky Way Sensor: Device Validation for Infiltrated Tissues (NCT07311733) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Milky Way Sensor: Device Validation for Infiltrated Tissues
United States28 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, CoumadinĀ®/warfarin, EliquisĀ®/apixaban).
* Fever at the time of study visit (ā„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
What they're measuring
1
Red Notification Sensitivity to Infiltrated Tissues
Timeframe: After each participant has been infiltrated, an expected average of 1 hour.