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Clinical Trials in the USA / NCT07009405
Recruiting Not applicable

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

NCT07009405 · tracked via the Priya Life Science USA tracker
Sponsor
Rhaeos, Inc
Phase
Not applicable
Started
2025-05-28
Last updated
2025-06-06

Condition(s) studied

IV InfiltrationIV Extravasation

Investigational drug(s) / intervention(s)

non-invasive thermal infusion site monitoring NTISM device

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

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Scheduled to receive an infusion therapy of at least 30 minutes in length 2. Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device 3. Signed informed consent 4. Available for 15 minutes of post-measurement monitoring following removal of the study device Exclusion Criteria: 1. Patient is under 12 years of age 2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm 3. 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 4. Investigator judges that the intravenous

Primary outcome measure(s)

  • Thermal skin measurements — Up to 12 hours of monitoring with a 15-minute follow-up period.
    Exploratory assessment of thermal skin measurements taken with the study device

Trial sites (1)

FacilityCityRegionStatus
Infusacare Skokie Illinois Recruiting

More Rhaeos, Inc. trials in the USA

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients Starting soon
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device Recruiting
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device Recruiting
Flow Detection in Open and Closed Shunt Valve Periods Recruiting
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009405 on ClinicalTrials.gov ↗ ← All trials in the USA