ivWatch Model 400: Device Validation for Non-Infiltrated Tissues

ivWatch

Status: Completed

Conditions: Infiltration of Peripheral IV Therapy

Treatments: Device: ivWatch Model 400

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120443

IVW400CS-05

Details and patient eligibility

About

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed consent
• Pass health screen
• 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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43 participants in 1 patient group

Non-Infiltrated Tissue

Experimental group

Description:

The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.

Treatment:

Device: ivWatch Model 400