Monitoring IV sites with a wireless thermal sensor during outpatient infusions
Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
This study will test a small wireless thermal sensor on people aged 12 and older having outpatient infusions of 30 minutes or more to see if it helps detect IV infiltration or extravasation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Rhaeos, Inc. Industry-sponsored |
| Locations | 1 site (Skokie, Illinois) |
| Trial ID | NCT07009405 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older scheduled for outpatient infusions lasting at least 30 minutes who have intact skin near the IV insertion site and can give informed consent.
Not a fit: Patients under 12, those with a history of serious adhesive skin reactions, those without suitable intact skin at the IV site, or those whose care would be disrupted by device placement are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could provide earlier, noninvasive warning of IV infiltration or extravasation and help reduce tissue injury and treatment interruptions.
How similar studies have performed: Use of thermal or skin‑based sensors to detect IV infiltration is a relatively new approach with limited published clinical evidence to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Skokie, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.