IV InfiltrationNCT07009405
Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During
A study testing non-invasive thermal infusion site monitoring NTISM device in people with IV Infiltration and IV Extravasation, run by Rhaeos, Inc. at 1 site in United States.
Trial summary
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- IV Infiltration, IV Extravasation
- What is being tested?
- non-invasive thermal infusion site monitoring NTISM device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled to receive an infusion therapy of at least 30 minutes in length
- Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device
- Signed informed consent
- Available for 15 minutes of post-measurement monitoring following removal of the study device
Who cannot join
- Patient is under 12 years of age
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm
- 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
- Investigator judges that the intravenous
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Infusacare
Skokie, Illinois, 60076
Matthew Dube, 8473246800
Matthew Dube
About this study
Official title: Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
- Conditions
- IV Infiltration, IV Extravasation
- Being tested
- non-invasive thermal infusion site monitoring NTISM device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive thermal infusion site monitoring NTISM deviceDevice
Non-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements
| Study group | Role | What they receive |
|---|---|---|
| IV Infusion Patients | Experimental | Pediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study. Receives: Device: non-invasive thermal infusion site monitoring NTISM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal skin measurements
Exploratory assessment of thermal skin measurements taken with the study device
Measured: Up to 12 hours of monitoring with a 15-minute follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start28 May 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IV InfiltrationStudies of the same condition, open and under way.
- More trials run by Rhaeos, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhaeos, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Chad Webb, Principal investigator, Rhaeos, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009405
- Sponsor's protocol ID
- 2025-02
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures
- ClinicalTrials.gov ID
- NCT07009405
- Acronym / sponsor ID
- 2025-02
- Conditions
- IV Infiltration, IV Extravasation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rhaeos, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Infusion Patients | Experimental | Device: non-invasive thermal infusion site monitoring NTISM devicePediatric patients over the age of 12 and adult patients with planned outpatient infusion procedures scheduled will be enrolled in this study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to receive an infusion therapy of at least 30 minutes in length
- Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device
- Signed informed consent
- Available for 15 minutes of post-measurement monitoring following removal of the study device
Key exclusion criteria (4 listed)
- Patient is under 12 years of age
- Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm
- 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
- Investigator judges that the intravenous
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive thermal infusion site monitoring NTISM deviceNon-invasive thermal infusion site monitoring NTISM device for detecting extravasation and infiltration events using thermal anisotropy measurements | Device | IV Infusion Patients |
Primary outcome
Thermal skin measurements
Time frame: Up to 12 hours of monitoring with a 15-minute follow-up period.
Exploratory assessment of thermal skin measurements taken with the study device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
R. Chad Webb principal investigator
Rhaeos, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive thermal infusion site monitoring NTISM device in people with IV Infiltration and IV Extravasation, run by Rhaeos, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Somera (855-814-3569, clinical@rhaeos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal skin measurements (time frame: Up to 12 hours of monitoring with a 15-minute follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.