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
Qualifiers
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
Treatments tested in this trial
- non-invasive thermal infusion site monitoring NTISM device
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov