Milky Way Sensor: Device Validation for Infiltrated Tissues

ivWatch

Status: Not yet enrolling

Conditions: Infiltration of Peripheral IV Therapy

Treatments: Device: ivWatch Model 400 with Milky Way Sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT07311733

IVW-CLR-CS38-400

Details and patient eligibility

About

A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Abnormal bleeding / hemophilia
• Absence of sensation in one or both arms
• Allergy to common medical materials
• Blood clotting disorder
• Currently enrolled in another clinical trial
• Current hepatitis infection or any history of hepatitis B or C
• Currently pregnant
• Daily regimen of blood thinning medication (e.g., aspirin, ibuprofen, naproxen, Coumadin®/warfarin, Eliquis®/apixaban).
• Fever at the time of study visit (≥100.4°F)
• Frequent dizziness or fainting spells, especially with needles
• History of chronic, severe anemia
• History of stroke
• HIV / Aids
• Immune deficiency disorder
• Lymphedema
• Major surgery or scar tissue which would complicate PIV access
• Needle phobia
• Radiation / chemotherapy in the last year
• Received IV therapy in 14 days prior to study visit
• Severe dehydration on day of study visit
• Sick or had an infection in 14 days prior to study visit
• Tattoo(s) that severely limits vein visualization at a sensor monitoring location
• Unstable or uncontrolled cardiopulmonary disorder
• Uncontrolled seizures

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Infiltrated Tissue

Experimental group

Description:

The ivWatch Milky Way 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 Milky Way Sensor