ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Infiltration of Peripheral IV Therapy Clinical Trial

Official title:

ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120443
• Other study ID #: IVW400CS-05
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: June 23, 2014
• Start date: January 2014
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: ivWatch, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Pass health screen

• 18 years or older

Exclusion Criteria:

• Fail health screen

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infiltration of Peripheral IV Therapy

Intervention

Device:
• ivWatch Model 400
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.

Locations

Country	Name	City	State
United States	ivWatch, LLC	Williamsburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ivWatch, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal Tissue Red Notification Rate	The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.	24 hours	No
Secondary	Normal Tissue Yellow Notification Rate	The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.	24 hours	No
Secondary	Significant Skin Irritation or Disruption to Skin Integrity	The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.	24 hours	Yes