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Not yet recruiting NCT07311733

Milky Way Sensor: Device Validation for Infiltrated Tissues

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 with Milky Way Sensor.
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
United States
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 →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Red Notification Sensitivity to Infiltrated Tissues [Time frame: After each participant has been infiltrated, an expected average of 1 hour.]
Secondary outcome measures (2)
  • Yellow Notification Sensitivity to Infiltrated Tissues [Time frame: After each participant has been infiltrated, an expected average of 1 hour.]
  • Significant Skin Irritation or Disruption to Skin Integrity [Time frame: After each participant has been infiltrated, an expected average of 1 hour.]

Eligibility criteria

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

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

United States · 1 center
  • ivWatch — Newport News

Identifiers

NCT: NCT07311733 · IVW-CLR-CS38-400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗