Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
NCT ID: NCT07009405
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-05-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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IV Infusion Patients
Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Rhaeos, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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R. Chad Webb
Role: PRINCIPAL_INVESTIGATOR
Rhaeos, Inc.
Locations
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Infusacare
Skokie, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Dube
Role: primary
Other Identifiers
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2025-02
Identifier Type: -
Identifier Source: org_study_id
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