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Clinical Trials/NCT04064229
NCT04064229
Completed
Not Applicable

ivWatch Sensor: Device Validation for Infiltrated Tissues

ivWatch, LLC1 site in 1 country99 target enrollmentApril 3, 2019
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ConditionsInfiltration of Peripheral IV Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infiltration of Peripheral IV Therapy
Sponsor
ivWatch, LLC
Enrollment
99
Locations
1
Primary Endpoint
Red Notification Sensitivity to Infiltrated Tissues
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 3, 2019
End Date
April 9, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

  • Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour)
  • Infiltrated Volume When Red Notification Issued(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)

Study Sites (1)

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