Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorRhaeos, Inc.
About this trial
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
non-invasive thermal infusion site monitoring NTISM device
DeviceNon-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: IV Infusion PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Thermal skin measurements
Exploratory assessment of thermal skin measurements taken with the study device
Time frame
Up to 12 hours of monitoring with a 15-minute follow-up period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov