ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

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.

Study Overview

• Status: Completed
• Conditions: Infiltration of Peripheral IV Therapy
• Intervention / Treatment: Device: ivWatch Model 400 with SmartTouch and fiber optic sensor

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Williamsburg, Virginia, United States, 23185
      • ivWatch, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Fail health screen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Non-Infiltrated Tissue; The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored a common peripheral IV site over a 24 hour observation period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: ivWatch, LLC
• Investigators: Study Director: Marisa Cole, Employee

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2019
• Primary Completion (ACTUAL): June 21, 2019
• Study Completion (ACTUAL): June 21, 2019

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IVW-CLR-CS24-400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No