ivWatch Model 400: Device Validation for Infiltrated Tissues

ivWatch, LLC1 site in 1 country71 target enrollmentFebruary 2014

ConditionsInfiltration of Peripheral IV Therapy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infiltration of Peripheral IV Therapy
Sponsor: ivWatch, LLC
Enrollment: 71
Locations: 1
Primary Endpoint: Red Notification Sensitivity to Infiltrated Tissues
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

February 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ivWatch, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent
•Pass health screen by clinician
•18 years or older

Exclusion Criteria

•Fail health screen

Outcomes

Primary Outcomes

Red Notification Sensitivity to Infiltrated Tissues

Time Frame: After each participant has been infiltrated, an expected average of 1 hour

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

Secondary Outcomes

Infiltrated Volume When Red Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour)
Infiltrated Volume When Yellow Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
Significant Skin Irritation or Disruption to Skin Integrity(After each participant has been infiltrated, an expected average of 1 hour)