ivWatch Sensor: Device Validation for Infiltrated Tissues

ivWatch

Status: Completed

Conditions: Infiltration of Peripheral IV Therapy

Treatments: Device: ivWatch Model 400 with Fiber Optic Sensor; Device: ivWatch Model 400 with SmartTouch Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04064229

IVW-CLR-CS27-400

Details and patient eligibility

About

A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Enrollment: 99 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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99 participants in 1 patient group

Infiltrated Tissue

Experimental group

Description:

The ivWatch Model 400 sensors 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: ivWatch Model 400 with Fiber Optic Sensor

Device: ivWatch Model 400 with SmartTouch Sensor