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

NCT07009405 | Recruiting FDA Device

• 1 other identifier: 2025-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IV Infiltration; IV Extravasation

Outcome Measures

Primary Outcomes (1)

• Thermal skin measurements

  Exploratory assessment of thermal skin measurements taken with the study device

  Up to 12 hours of monitoring with a 15-minute follow-up period.

Study Arms (1)

IV Infusion Patients

EXPERIMENTAL

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

Device: non-invasive thermal infusion site monitoring NTISM device

Interventions

non-invasive thermal infusion site monitoring NTISM device DEVICE

Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements

IV Infusion Patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (1)

Infusacare

Skokie, Illinois, 60076, United States

RECRUITING

Study Officials

• R. Chad Webb

  Rhaeos, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Somera

CONTACT

855-814-3569; clinical@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: May 28, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)