Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During

Rhaeos

Status: Enrolling

Conditions: IV Extravasation; IV Infiltration

Treatments: Device: non-invasive thermal infusion site monitoring NTISM device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07009405

2025-02

Details and patient eligibility

About

This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

IV Infusion Patients

Experimental group

Description:

Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study.

Treatment:

Device: non-invasive thermal infusion site monitoring NTISM device