Milky Way Sensor Motion Validation

Milky Way Sensor: Device Validation for Non-Infiltrated Tissues

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infiltration of Peripheral IV Therapy
• Intervention / Treatment: Device: ivWatch Model 400

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Naramore CTO, MS; Phone Number: (855) 489-2824; Email: jason.naramore@ivwatch.com
• Study Contact Backup: Name: Marisa Brown, BS; Phone Number: (855) 489-2824; Email: marisa.brown@ivwatch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age or older
• Healthy individual, verified by an eligible designation on the Health History Form

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Infiltrated Tissue; The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.	Device: ivWatch Model 400; The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ivWatch, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 14, 2025

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: motion
• Other Study ID Numbers: IVW-CLR-CS37-400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No