N/A
N=71
ivWatch Model 400: Device Validation for Infiltrated Tissues
Infiltration of Peripheral IV Therapy
Bottom Line
View on ClinicalTrials.gov: NCT02123745 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Red Notification Sensitivity to Infiltrated Tissues — 96.4 percentage of infiltrations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The ivWatch Model 400 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ivWatch, LLC
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Red Notification Sensitivity to Infiltrated Tissues |
96.4 | — |
| SECONDARY Yellow Notification Sensitivity to Infiltrated Tissues |
99.3 | — |
| SECONDARY Infiltrated Volume When Red Notification Issued |
3.75 | — |
| SECONDARY Infiltrated Volume When Yellow Notification Issued |
3.49 | — |
| SECONDARY Significant Skin Irritation or Disruption to Skin Integrity |
— | — |
Summary
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
Eligibility Criteria
Inclusion Criteria
- Informed consent
- Pass health screen by clinician
- 18 years or older
Exclusion Criteria
- Fail health screen
Data sourced from ClinicalTrials.gov (NCT02123745). 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.