Infiltration of Peripheral IV TherapyNCT07228416
Milky Way Sensor Motion Validation
A study testing ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC at 1 site in United States.
Trial summary
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infiltration of Peripheral IV Therapy
- What is being tested?
- ivWatch Model 400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Healthy individual, verified by an eligible designation on the Health History Form
Who cannot join
- Currently enrolled in another clinical trial
- Currently pregnant or trying to become pregnant
- Serious and uncontrolled medical condition
- Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location
- Medical adhesive allergy
- Sleepwalking occurrence in the last year
Show all 10Show fewer
- Current drug/alcohol dependence
- Sick or had an infection in the last 14 days
- Hospitalized in the last 14 days
- Fever at the time of study visit (≥100.4°F)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Milky Way Sensor: Device Validation for Non-Infiltrated Tissues
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Conditions
- Infiltration of Peripheral IV Therapy
- Being tested
- ivWatch Model 400
- Keywords
- motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivWatch Model 400Device
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
| Study group | Role | What they receive |
|---|---|---|
| Non-Infiltrated Tissue | Experimental | The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. Receives: Device: ivWatch Model 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Check IV Notification Rate Per Day
The ivWatch Model 400 issues Check IV notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a negative binomial regression model.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Feb 2026
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infiltration of Peripheral IV TherapyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228416
- Sponsor's protocol ID
- IVW-CLR-CS37-400
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milky Way Sensor: Device Validation for Non-Infiltrated Tissues
- ClinicalTrials.gov ID
- NCT07228416
- Acronym / sponsor ID
- IVW-CLR-CS37-400
- Conditions
- Infiltration of Peripheral IV Therapy
- Keywords
- motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Infiltrated Tissue | Experimental | Device: ivWatch Model 400The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Healthy individual, verified by an eligible designation on the Health History Form
Key exclusion criteria (10 listed)
- Currently enrolled in another clinical trial
- Currently pregnant or trying to become pregnant
- Serious and uncontrolled medical condition
- Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location
- Medical adhesive allergy
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 |
|---|---|---|
| ivWatch Model 400The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. | Device | Non-Infiltrated Tissue |
Primary outcome
Red Check IV Notification Rate Per Day
Time frame: 24 Hours
The ivWatch Model 400 issues Check IV notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a negative binomial regression model.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivWatch Model 400 in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 17 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Check IV Notification Rate Per Day (time frame: 24 Hours). 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 17 Aug 2026.