N/A
Completed N=99
ivWatch Sensor: Device Validation for Infiltrated Tissues
Infiltration of Peripheral IV Therapy
Source: ClinicalTrials.gov NCT04064229 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Red Notification Sensitivity to Infiltrated Tissues — 99.0; 99.0 percentage of infiltrations detected
Summary
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Red Notification Sensitivity to Infiltrated Tissues |
99.0; 99.0 | — |
| SECONDARY Yellow Notification Sensitivity to Infiltrated Tissues |
99.0; 99.0 | — |
| SECONDARY Infiltrated Volume When Red Notification Issued |
1.75; 4.33 | — |
| SECONDARY Infiltrated Volume When Yellow Notification Issued |
1.66; 3.90 | — |
| SECONDARY Significant Skin Irritation or Disruption to Skin Integrity |
0; 0 | — |
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 (NCT04064229). 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.