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NCT01834612 Clinical Trial

Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

Blood Loss Clinical Trial

Official title:
Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01834612
Other study ID # Zynex 750
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 7, 2013
Est. completion date March 11, 2013

Study information
Verified date July 2021
Source Zynex Monitoring Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if a manual blood loss can be detected using the non-invasive blood monitor.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 11, 2013
Est. primary completion date March 11, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - healthy volunteer - between 18 to 50 years of age - weight between 157 to 220 lbs Exclusion Criteria: - unstable or untreated cardia disease - alcohol consumption in 24 hours prior to screening - tobacco use in 4 hours prior to screening - pregnancy - infection - Hemoglobin < 12.5 g/dL at time of procedure

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CM1500
blood volume monitor

Locations
Country Name City State
United States DaVita Clinical Research Lakewood 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 by non-invasive monitoring during whole blood draw 4 months
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