ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ivWatch, LLC
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Normal Tissue Red Notification Rate
Study Overview
Brief Summary
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Informed consent
- •Pass health screen
- •18 years or older
Exclusion Criteria
- •Fail health screen
Arms & Interventions
Non-Infiltrated Tissue
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
Intervention: ivWatch Model 400 (Device)
Outcomes
Primary Outcomes
Normal Tissue Red Notification Rate
Time Frame: 24 hours
The ivWatch Model 400 issues red 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 the Clopper-Pearson method.
Secondary Outcomes
- Normal Tissue Yellow Notification Rate(24 hours)
- Significant Skin Irritation or Disruption to Skin Integrity(24 hours)
Investigators
Garret Bonnema
Chief Science Officer
ivWatch, LLC