NCT07009405 Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
| NCT ID | NCT07009405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhaeos, Inc. |
| Condition | IV Infiltration |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Eligibility Criteria
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