RecruitingNot ApplicableNCT07009405
Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
Sponsor
Rhaeos, Inc.
Enrollment
10 participants
Start Date
May 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Eligibility
Min Age: 12 Years
Inclusion Criteria4
- 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 Criteria4
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEnon-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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07009405