Monitoring IV sites with a wireless thermal sensor during outpatient infusions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will have a non‑invasive Thermal Infusion Site Monitor (NTISM) placed on intact skin near their IV catheter during routine outpatient infusion treatments. The device records skin temperature signals throughout the infusion and is removed after treatment, followed by 15 minutes of post‑device monitoring. Eligible participants must be at least 12 years old, have appropriate intact skin at the IV site, and be able to provide consent. The study is conducted at a single outpatient infusion center in Skokie, Illinois, and is designed to observe device performance during normal clinical use.

Why it matters

Who can join: the full rules

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

Where it's running

• Infusacare
  Skokie, Illinois, United States Recruiting

Study contacts

• Principal investigator: R. Chad Webb — Rhaeos, Inc.
• Study coordinator: Anna Somera
• Email: clinical@rhaeos.com
• Phone: 855-814-3569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.