ivWatch Model 400: Device Validation for Infiltrated Tissues

ivWatch

Status: Completed

Conditions: Infiltration of Peripheral IV Therapy

Treatments: Device: The ivWatch Model 400

Study type: Interventional

Funder types: Industry

Identifiers

NCT02123745

IVW400CS-06

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Fail health screen

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Infiltrated Tissue

Experimental group

Description:

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.

Treatment:

Device: The ivWatch Model 400