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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Red Notification Sensitivity to Infiltrated Tissues
Timeframe: After each participant has been infiltrated, an expected average of 1 hour.