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Smart sensor could warn nurses when IV fluids leak into tissue

NCT ID NCT07311733

Diagnosis Sponsor: ivWatch, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tests a device called the ivWatch Model 400 with Milky Way Sensor, which monitors IV sites and alerts if fluids leak into surrounding tissue. Researchers will enroll 28 healthy adults and deliberately create small, controlled leaks to see how well the sensor detects them. The goal is to improve patient safety during IV therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivWatch Model 400 with Milky Way Sensor (a monitoring device)
What this could lead to
If it works, this sensor could help nurses catch IV leaks early, reducing pain and injury for patients.
What could go wrong
This is a very small, early study with only 28 healthy volunteers. The sensor may not work as well in real hospital settings or in sicker patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infiltration of peripheral iv therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ivWatch

    Newport News, Virginia, 23606, United States

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