ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infiltration of Peripheral IV Therapy
- Sponsor
- ivWatch, LLC
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Normal Tissue Red Notification Rate
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Garret Bonnema
Chief Science Officer
ivWatch, LLC
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •Pass health screen
- •18 years or older
Exclusion Criteria
- •Fail health screen
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)