Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

Zynex Monitoring Solutions

Status and phase

Completed

Phase 1

Conditions

Healthy

Blood Loss

Treatments

Device: CM-1500

Study type

Interventional

Funder types

Industry

Identifiers

NCT01646060

ZM-11-01

Details and patient eligibility

About

Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.

Enrollment

10 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written informed consent
Male, 18-65 years of age
Subject is suitable for a blood draw of a pint of blood
Weighs at least 110 pounds

Exclusion criteria

Subject has a heart condition that may interfere with the Zynex CM-1500
Subject has unstable or untreated heart disease
Subject has been diagnosed with chronic fatigue syndrome
Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
Subject donated blood within 8 weeks prior to blood draw
Subject has high or low blood pressure on the day of blood draw
Subject hemoglobin < 12.5 g/dL