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

Phase 1

Completed

• Conditions: Blood Loss; Healthy
• Interventions: Device: CM-1500

• Registration Number: NCT01646060
• Lead Sponsor: Zynex Monitoring Solutions

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-28
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-17
• Last Update Submitted: 2012-07-17
• Study First Posted: 2012-07-20
• Last Update Posted: 2012-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Draw	CM-1500	-

Primary Outcome Measures

Name	Time	Method
Detect change in blood volume during blood draw	15-30 minutes

Secondary Outcome Measures

Name	Time	Method
Detect insidious bleeding	15-30 minutes

Trial Locations

Locations (1)

Rocky Mountain Urgent Care; 🇺🇸 Aurora, Colorado, United States