An interventional study of non-invasive thermal infusion site monitoring NTISM device in IV Infiltration and IV Extravasation, sponsored by Rhaeos, Inc.. Recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Device feasibility
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Rhaeos, Inc. is the lead sponsor of 16 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements
Thermal skin measurements
Exploratory assessment of thermal skin measurements taken with the study device
Time frame: Up to 12 hours of monitoring with a 15-minute follow-up period.
Plan to share: No
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Rhaeos, Inc.