Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
Part of paid clinical trials in Skokie, Illinois.
- Sponsor
- Rhaeos, Inc.
- Study ID
- NCT07009405
- Status
- Recruiting
Conditions
- IV Extravasation
- IV Infiltration
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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
Study Details
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Key Dates
- Start date
- May 28, 2025
- Status verified
- May 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: IV Infusion PatientsPediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study.
Primary Outcome Measure
Thermal skin measurements [ Time Frame: Up to 12 hours of monitoring with a 15-minute follow-up period. ]
Central Contacts
- Anna Somera855-814-3569
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Infusacare | Skokie | Illinois | 60076 | Matthew Dube 8473246800 Matthew Dube (PRINCIPAL_INVESTIGATOR) |
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