Milky Way Sensor: Device Validation for Infiltrated Tissues
Starting soon · Not applicable
Conditions studied: Infiltration of Peripheral IV Therapy
In brief
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.
Key facts
- Study ID
- NCT07311733
- Run by
- ivWatch, LLC
- People needed
- 28
- Starts
- 2026-01-01
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 years of age or older
- Healthy, verified by an eligible designation on the Health History Form
You may not qualify if…
- 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
Where it is running
- ivWatch — Newport News, Virginia, United States
Full record on ClinicalTrials.gov
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