ivWatch Model 400: Device Validation for Infiltrated Tissues

NCT ID: NCT02123745

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Infiltration of Peripheral IV Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Infiltrated Tissue

The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.

Group Type: EXPERIMENTAL

The ivWatch Model 400

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Fail health screen

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ivWatch, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ivWatch, LLC

Williamsburg, Virginia, United States

Countries

United States

Other Identifiers

IVW400CS-06

Identifier Type: -

Identifier Source: org_study_id