N/A
Completed N=71
ivWatch Model 400: Device Validation for Infiltrated Tissues
Infiltration of Peripheral IV Therapy
Source: ClinicalTrials.gov NCT02123745 ↗
Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Red Notification Sensitivity to Infiltrated Tissues — 96.4 percentage of infiltrations
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.
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 |
— | — |
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. Informational only — not medical advice.