Milky Way Sensor: Device Validation for Infiltrated Tissues
Part of paid clinical trials in Newport News, Virginia.
- Sponsor
- ivWatch, LLC
- Study ID
- NCT07311733
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Infiltration of Peripheral IV Therapy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- ivWatch Model 400 with Milky Way Sensor — DEVICEThe 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.
Study Details
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 Dates
- Start date
- Jan 31, 2026
- Status verified
- Dec 2025
- Primary completion
- Feb 28, 2026
- Completion
- Feb 28, 2026
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Infiltrated TissueThe 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.
Primary Outcome Measure
Red Notification Sensitivity to Infiltrated Tissues [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour. ]
Central Contacts
- Jason Naramore, MS(855) 489-2824
- Marisa Brown, BS(855) 489-2824
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ivWatch | Newport News | Virginia | 23606 |
Find similar trials in Newport News, VA
By research site