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NCT07009405NARecruiting

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

Rhaeos, Inc.

Start Date

5/28/2025

Completion Date

12/1/2025

Summary

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

Eligibility Criteria

Age Range: 12 years to No maximum

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

Interventions

DEVICE

non-invasive thermal infusion site monitoring NTISM device

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Conditions

IV InfiltrationIV Extravasation

Locations

Infusacare

Skokie, Illinois 60076

United States