Milky Way Sensor Motion Validation

ivWatch

Status: Not yet enrolling

Conditions: Infiltration of Peripheral IV Therapy

Treatments: Device: ivWatch Model 400

Study type: Interventional

Funder types: Industry

Identifiers

NCT07228416

IVW-CLR-CS37-400

Details and patient eligibility

About

A single arm study of 20 adult volunteers to assess the safety and efficacy of the ivWatch sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Healthy individual, verified by an eligible designation on the Health History Form

Exclusion criteria

• Currently enrolled in another clinical trial
• Currently pregnant or trying to become pregnant
• Serious and uncontrolled medical condition
• Tattoo(s), scarring, or bruising that severely limits vein visualization at a sensor monitoring location
• Medical adhesive allergy
• Sleepwalking occurrence in the last year
• Current drug/alcohol dependence
• Sick or had an infection in the last 14 days
• Hospitalized in the last 14 days
• Fever at the time of study visit (≥100.4°F)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 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