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
Conditions
IV InfiltrationIV Extravasation
Locations
Infusacare
Skokie, Illinois 60076
United States