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NCT Number: NCT07009405

Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During

This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.

Recruiting

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Key information

Conditions

IV Infiltration IV Extravasation

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infusacare

Skokie, Illinois, 60076, United States

Location status: Recruiting

Location contact

Matthew Dube

CONTACT

8473246800

Matthew Dube

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled to receive an infusion therapy of at least 30 minutes in length
  • Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device
  • Signed informed consent
  • Available for 15 minutes of post-measurement monitoring following removal of the study device

Exclusion criteria

  • Patient is under 12 years of age
  • Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm
  • Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
  • Investigator judges that the intravenous

Treatment and study plan

non-invasive thermal infusion site monitoring NTISM device

Device

Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements

Primary outcomes

  1. Thermal skin measurements

    Time frame: Up to 12 hours of monitoring with a 15-minute follow-up period.

    Exploratory assessment of thermal skin measurements taken with the study device

Study contacts

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

Anna Somera

CONTACT

[email protected]

855-814-3569

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Official study title

Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Jun 6, 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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