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NCT Number: NCT07311733

Milky Way Sensor: Device Validation for Infiltrated Tissues

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.

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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

Primary location

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, 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

Treatment and study plan

ivWatch Model 400 with Milky Way Sensor

Device

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 outcomes

  1. Red Notification Sensitivity to Infiltrated Tissues

    Time frame: After each participant has been infiltrated, an expected average of 1 hour.

    The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Secondary outcomes

  1. Yellow Notification Sensitivity to Infiltrated Tissues

    Time frame: After each participant has been infiltrated, an expected average of 1 hour.

    The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

  2. Significant Skin Irritation or Disruption to Skin Integrity

    Time frame: After each participant has been infiltrated, an expected average of 1 hour.

    The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.

Study contacts

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

Jason Naramore, 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 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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