N/A N=99 Diagnostic

ivWatch Sensor: Device Validation for Infiltrated Tissues

Infiltration of Peripheral IV Therapy

Bottom Line

View on ClinicalTrials.gov: NCT04064229 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Red Notification Sensitivity to Infiltrated Tissues — 99.0; 99.0 percentage of infiltrations detected

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ivWatch Model 400 with SmartTouch Sensor (Device); ivWatch Model 400 with Fiber Optic Sensor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ivWatch, LLC
Primary completion: Apr 2019

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	—

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.

Eligibility Criteria

Inclusion Criteria

Informed Consent
Pass health screen by clinician
18 years or older

Exclusion Criteria

Fail health screen

View full record on ClinicalTrials.gov →

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.