IV Extravasation, IV Infiltration
Conditions
Brief summary
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
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
Sponsors
Rhaeos, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thermal skin measurements | Up to 12 hours of monitoring with a 15-minute follow-up period. | Exploratory assessment of thermal skin measurements taken with the study device |
Countries
United States
Contacts
Primary ContactAnna Somera
Outcome results
None listed