Milky Way Sensor: Device Validation for Infiltrated Tissues

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • Virginia
    • Newport News, Virginia, United States, 23606
      • ivWatch
      • Contact: 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, verified by an eligible designation on the Health History Form

Exclusion Criteria:

• 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
• 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

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: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yellow Notification Sensitivity to Infiltrated Tissues	The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow 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.
Significant Skin Irritation or Disruption to Skin Integrity	The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.	After each participant has been infiltrated, an expected average of 1 hour.

Collaborators and Investigators

• Sponsor: ivWatch, LLC

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IVW-CLR-CS38-400

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