ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

Infiltration of Peripheral IV Therapy Clinical Trial

Official title:

ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065373
• Other study ID #: IVW-CLR-CS24-400
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: June 21, 2019

Study information

• Verified date: August 2019
• Source: ivWatch, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Pass health screen

• 18 years or older

Exclusion Criteria:

• Fail health screen

Related Conditions & MeSH terms

• Infiltration of Peripheral IV Therapy

Intervention

Device:
• ivWatch Model 400 with SmartTouch and fiber optic sensor
The ivWatch Model 400 with SmartTouch or fiber optic sensor 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 a negative binomial regression model.	24 Hours
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 a negative binomial regression model.	24 Hours
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