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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646060
• Other study ID #: ZM-11-01
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2011
• Last updated: July 17, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Zynex Monitoring Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Loss
• Healthy
• Hemorrhage

Intervention

Device:
• CM-1500
Blood Volume Monitor

Locations

Country	Name	City	State
United States	Rocky Mountain Urgent Care	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Zynex Monitoring Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect change in blood volume during blood draw		15-30 minutes	No
Secondary	Detect insidious bleeding		15-30 minutes	Yes