Recruiting NCT07009405

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

No phase Interventional IV Infiltration IV Extravasation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: non-invasive thermal infusion site monitoring NTISM device.
Who it may be relevant to: Registry conditions: IV Infiltration, IV Extravasation. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures

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

Device non-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

Thermal skin measurements [Time frame: Up to 12 hours of monitoring with a 15-minute follow-up period.]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07009405 · 2025-02