N/A
N=43
ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Infiltration of Peripheral IV Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02120443 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Normal Tissue Red Notification Rate — 0.24 red notifications per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ivWatch Model 400 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ivWatch, LLC
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normal Tissue Red Notification Rate |
0.24 | — |
| SECONDARY Normal Tissue Yellow Notification Rate |
0.51 | — |
| SECONDARY Significant Skin Irritation or Disruption to Skin Integrity |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Informed consent
- Pass health screen
- 18 years or older
Exclusion Criteria
- Fail health screen
Data sourced from ClinicalTrials.gov (NCT02120443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.