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Not yet recruiting NCT07228416

Milky Way Sensor Motion Validation

No phase Interventional Infiltration of Peripheral IV Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ivWatch Model 400.
Who it may be relevant to
Registry conditions: Infiltration of Peripheral IV Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Milky Way Sensor: Device Validation for Non-Infiltrated Tissues

Overview

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.

Interventions

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

Primary outcome measures

  • Check IV notification rate per day [Time frame: 24 Hours]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07228416 · IVW-CLR-CS37-400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗