Infiltration of Peripheral IV TherapyNCT07311733
Milky Way Sensor: Device Validation for Infiltrated Tissues
A study testing ivWatch Model 400 with Milky Way Sensor in people with Infiltration of Peripheral IV Therapy, run by ivWatch, LLC at 1 site in United States.
Trial summary
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy. 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 with Milky Way Sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Feb 2026
- 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 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, verified by an eligible designation on the Health History Form
Who cannot join
- Abnormal bleeding / hemophilia
- Absence of sensation in one or both arms
- Allergy to common medical materials
- Blood clotting disorder
- Currently enrolled in another clinical trial
- Current hepatitis infection or any history of hepatitis B or C
Show all 24Show fewer
- Currently pregnant
- Daily regimen of blood thinning medication (e.g., aspirin, ibuprofen, naproxen, Coumadin®/warfarin, Eliquis®/apixaban).
- Fever at the time of study visit (≥100.4°F)
- Frequent dizziness or fainting spells, especially with needles
- History of chronic, severe anemia
- History of stroke
- HIV / Aids
- Immune deficiency disorder
- Lymphedema
- Major surgery or scar tissue which would complicate PIV access
- Needle phobia
- Radiation / chemotherapy in the last year
- Received IV therapy in 14 days prior to study visit
- Severe dehydration on day of study visit
- Sick or had an infection in 14 days prior to study visit
- Tattoo(s) that severely limits vein visualization at a sensor monitoring location
- Unstable or uncontrolled cardiopulmonary disorder
- Uncontrolled seizures
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
ivWatch
Newport News, Virginia, 23606
Marisa Brown, BS, (855) 489-2824, marisa.brown@ivwatch.com
About this study
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Conditions
- Infiltration of Peripheral IV Therapy
- Being tested
- ivWatch Model 400 with Milky Way Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivWatch Model 400 with Milky Way SensorDevice
The ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
| Study group | Role | What they receive |
|---|---|---|
| Infiltrated Tissue | Experimental | The ivWatch Milky Way sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. Receives: Device: ivWatch Model 400 with Milky Way Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Notification Sensitivity to Infiltrated Tissues
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Measured: After each participant has been infiltrated, an expected average of 1 hour.
Secondary outcomes (2)
Yellow Notification Sensitivity to Infiltrated Tissues
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Measured: After each participant has been infiltrated, an expected average of 1 hour.
Significant Skin Irritation or Disruption to Skin Integrity
The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
Measured: After each participant has been infiltrated, an expected average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ivWatch, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311733
- Sponsor's protocol ID
- IVW-CLR-CS38-400
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milky Way Sensor: Device Validation for Infiltrated Tissues
- ClinicalTrials.gov ID
- NCT07311733
- Acronym / sponsor ID
- IVW-CLR-CS38-400
- Conditions
- Infiltration of Peripheral IV Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- ivWatch, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Dec 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.
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infiltrated Tissue | Experimental | Device: ivWatch Model 400 with Milky Way SensorThe ivWatch Milky Way sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr. |
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, verified by an eligible designation on the Health History Form
Key exclusion criteria (24 listed)
- Abnormal bleeding / hemophilia
- Absence of sensation in one or both arms
- Allergy to common medical materials
- Blood clotting disorder
- Currently enrolled in another clinical trial
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 400 with Milky Way SensorThe ivWatch Model 400 with Milky Way Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected. | Device | Infiltrated Tissue |
Primary outcome
Red Notification Sensitivity to Infiltrated Tissues
Time frame: After each participant has been infiltrated, an expected average of 1 hour.
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
2 secondary outcomes
Yellow Notification Sensitivity to Infiltrated Tissues
Time frame: After each participant has been infiltrated, an expected average of 1 hour.
Significant Skin Irritation or Disruption to Skin Integrity
Time frame: After each participant has been infiltrated, an expected average of 1 hour.
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 31 Dec 2025.
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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.
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 with Milky Way Sensor 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 24 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: opening soon, as of the sponsor's last update on 31 Dec 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 Jason Naramore, MS ((855) 489-2824, jason.naramore@ivwatch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Notification Sensitivity to Infiltrated Tissues (time frame: After each participant has been infiltrated, an expected average of 1 hour.). 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 31 Dec 2025.