ivWatch Model 400: Device Validation for Infiltrated Tissues

Infiltration of Peripheral IV Therapy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123745
• Other study ID #: IVW400CS-06
• Status: Completed
• Phase: N/A
• First received: April 22, 2014
• Last updated: May 27, 2014
• Start date: February 2014
• Est. completion date: February 2014

Study information

• Verified date: May 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Pass health screen by clinician

• 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:
• The ivWatch Model 400
The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

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	Red Notification Sensitivity to Infiltrated Tissues	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.	After each participant has been infiltrated, an expected average of 1 hour	No
Secondary	Yellow Notification Sensitivity to Infiltrated Tissues	The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.	After each participant has been infiltrated, an expected average of 1 hour	No
Secondary	Infiltrated Volume When Red Notification Issued	The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.	After each participant has been infiltrated, an expected average of 1 hour	No
Secondary	Infiltrated Volume When Yellow Notification Issued	The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.	After each participant has been infiltrated, an expected average of 1 hour	No
Secondary	Significant Skin Irritation or Disruption to Skin Integrity	The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.	After each participant has been infiltrated, an expected average of 1 hour	Yes