Milky Way Sensor Motion Validation

August 13, 2026 updated by: ivWatch, LLC

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Newport News, Virginia, United States, 23606
        • ivWatch LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Red Check IV Notification Rate Per Day
Time Frame: 24 Hours
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

This is where you will find people and organizations involved with this study.

Sponsor

ivWatch, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Actual)

February 25, 2026

Study Completion (Actual)

February 25, 2026

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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