RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures

Quick Facts

Study Start:2025-05-28

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07009405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Anna Somera

CONTACT

855-814-3569

clinical@rhaeos.com

Principal Investigator

R. Chad Webb

PRINCIPAL_INVESTIGATOR

Rhaeos, Inc.

Study Locations (Sites)

Infusacare

Skokie, Illinois, 60076

United States

Collaborators and Investigators

Sponsor: Rhaeos, Inc.

R. Chad Webb, PRINCIPAL_INVESTIGATOR, Rhaeos, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-05-28

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

IV Infiltration
IV Extravasation