Milky Way Sensor Motion Validation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorivWatch, LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years of age or older
Healthy individual, verified by an eligible designation on the Health History Form
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ivWatch Model 400
DeviceThe ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Non-Infiltrated TissueExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 HoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: