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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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IV Infiltration IV Extravasation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

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.

Group Type EXPERIMENTAL

non-invasive thermal infusion site monitoring NTISM device

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhaeos, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R. Chad Webb

Role: PRINCIPAL_INVESTIGATOR

Rhaeos, Inc.

Locations

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Infusacare

Skokie, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Somera

Role: CONTACT

855-814-3569

Facility Contacts

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Matthew Dube

Role: primary

8473246800

Other Identifiers

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2025-02

Identifier Type: -

Identifier Source: org_study_id

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