Milky Way Sensor Motion Validation

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.

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Key information

Conditions

Infiltration of Peripheral IV Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ivWatch Model 400

Device

The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Naramore CTO, MS

CONTACT

[email protected]

(855) 489-2824

Marisa Brown, BS

CONTACT

[email protected]

(855) 489-2824

Sponsors and collaborators

Lead sponsor

ivWatch, LLC

Industry

Registry information

Official study title

Milky Way Sensor: Device Validation for Non-Infiltrated Tissues

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 14, 2025
Registry last updated: Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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