Milky Way Sensor: Device Validation for Infiltrated Tissues
NCT ID: NCT07311733
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
28 participants
INTERVENTIONAL
2026-01-31
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Infiltrated Tissue
The ivWatch Milky Way sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
ivWatch 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.
Interventions
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ivWatch 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.
Eligibility Criteria
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Inclusion Criteria
* Healthy, verified by an eligible designation on the Health History Form
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ivWatch, LLC
INDUSTRY
Responsible Party
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Locations
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ivWatch
Newport News, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Marisa Brown, BS
Role: primary
Other Identifiers
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IVW-CLR-CS38-400
Identifier Type: -
Identifier Source: org_study_id