Milky Way Sensor Motion Validation
Milky Way Sensor: Device Validation for Non-Infiltrated Tissues
1 other identifier
interventional
20
1 country
1
Brief Summary
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2025
CompletedFirst Posted
Study publicly available on registry
November 14, 2025
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2026
CompletedResults Posted
Study results publicly available
August 17, 2026
CompletedAugust 17, 2026
August 1, 2026
20 days
November 12, 2025
July 20, 2026
August 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Red Check IV Notification Rate Per Day
The ivWatch Model 400 issues Check IV notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a negative binomial regression model.
24 Hours
Study Arms (1)
Non-Infiltrated Tissue
EXPERIMENTALThe ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
Interventions
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
Eligibility Criteria
You may qualify if:
- years of age or older
- Healthy individual, verified by an eligible designation on the Health History Form
You may not qualify if:
- Currently enrolled in another clinical trial
- Currently pregnant or trying to become pregnant
- Serious and uncontrolled medical condition
- Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location
- Medical adhesive allergy
- Sleepwalking occurrence in the last year
- Current drug/alcohol dependence
- Sick or had an infection in the last 14 days
- Hospitalized in the last 14 days
- Fever at the time of study visit (≥100.4°F)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ivWatch, LLClead
Study Sites (1)
ivWatch LLC
Newport News, Virginia, 23606, United States
Results Point of Contact
- Title
- Jason Naramore
- Organization
- ivWatch
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2025
First Posted
November 14, 2025
Study Start
February 5, 2026
Primary Completion
February 25, 2026
Study Completion
February 25, 2026
Last Updated
August 17, 2026
Results First Posted
August 17, 2026
Record last verified: 2026-08