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

Launched by RHAEOS, INC. · May 29, 2025

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ClinConnect Summary

This clinical trial is studying a new device called the Non-invasive Thermal Infusion Site Monitor (NTISM). The goal is to see how well this device works during outpatient infusion treatments, which are procedures where patients receive medications through an intravenous (IV) line. The trial specifically looks at issues related to IV infiltration and extravasation, which occur when the IV fluid leaks into the surrounding tissue instead of staying in the vein.

To participate in the study, you need to be scheduled for an infusion that lasts at least 30 minutes and have a suitable area of skin near the IV site where the device can be applied. You must also be at least 12 years old and able to provide signed consent. After the device is used, you will be monitored for about 15 minutes. It's important to note that if you have had serious skin reactions to certain adhesives or if participating could interfere with your medical care, you may not be eligible for this trial. Overall, this study aims to improve the safety and effectiveness of outpatient infusion treatments.

Gender

ALL

Eligibility criteria

• 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