Milky Way Sensor: Device Validation for Infiltrated Tissues
1 other identifier
interventional
28
1 country
1
Brief 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.
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 Jan 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
December 29, 2025
CompletedFirst Posted
Study publicly available on registry
December 31, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedDecember 31, 2025
December 1, 2025
1 month
December 29, 2025
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Red Notification Sensitivity to Infiltrated Tissues
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
After each participant has been infiltrated, an expected average of 1 hour.
Secondary Outcomes (2)
Yellow Notification Sensitivity to Infiltrated Tissues
After each participant has been infiltrated, an expected average of 1 hour.
Significant Skin Irritation or Disruption to Skin Integrity
After each participant has been infiltrated, an expected average of 1 hour.
Study Arms (1)
Infiltrated Tissue
EXPERIMENTALThe 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.
Interventions
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
You may qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ivWatch, LLClead
Study Sites (1)
ivWatch
Newport News, Virginia, 23606, United States
Central Study Contacts
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
December 29, 2025
First Posted
December 31, 2025
Study Start
January 1, 2026
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
December 31, 2025
Record last verified: 2025-12