Recruiting

NTISM

Sponsor:

Rhaeos, Inc.

Code:

NCT07009405

Conditions

IV Infiltration

IV Extravasation

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

non-invasive thermal infusion site monitoring NTISM device

Study Details

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

Study ID

NCT07009405

Start date

May 28, 2025

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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

Primary outcome measure

  • Thermal skin measurements [ Time Frame: Up to 12 hours of monitoring with a 15-minute follow-up period. ]

Central Contacts and Locations

Central contacts

Anna Somera

855-814-3569clinical@rhaeos.com

Locations

Infusacare

Recruiting

Skokie, Illinois, United States, 60076

Contacts

Matthew Dube

8473246800

Principal Investigator:

Matthew Dube

More Information

Sponsor

Rhaeos, Inc.

Last update posted

Jun 6, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rhaeos, Inc. on 2025-06-06.