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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Zynex Monitoring Solutions

ClinicalTrials.gov Identifier:

NCT01834612

First received: April 15, 2013

Last updated: April 17, 2013

Last verified: April 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Blood Loss	Device: CM1500	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw

Resource links provided by NLM:

MedlinePlus related topics: Bleeding

U.S. FDA Resources

Further study details as provided by Zynex Monitoring Solutions:

Primary Outcome Measures:

Detect change in blood volume by non-invasive monitoring during whole blood draw [ Time Frame: 4 months ]


Estimated Enrollment:	40
Study Start Date:	January 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Blood draw CM1500 with blood draw	Device: CM1500 blood volume monitor
Sham Comparator: No blood draw CM 1500 with no blood draw	Device: CM1500 blood volume monitor

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834612

Contacts


Contact: Chris Galloway, MD	303-566-3002

Locations


United States, Colorado
DaVita Clinical Research	Recruiting
Lakewood, Colorado, United States, 80228
Contact: Mary Cook, RN, BSN 303-566-3002
Principal Investigator: Chris Galloway, MD

Sponsors and Collaborators

Zynex Monitoring Solutions

Investigators


Principal Investigator:	Chris Galloway, MD	Davita Clinical Research

More Information


Responsible Party:	Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:	NCT01834612 History of Changes
Other Study ID Numbers:	Zynex 750
Study First Received:	April 15, 2013
Last Updated:	April 17, 2013

Keywords provided by Zynex Monitoring Solutions:


blood loss, hemorrhage, hemorrhagic shcok

Additional relevant MeSH terms:


Hemorrhage Pathologic Processes

ClinicalTrials.gov processed this record on June 28, 2017

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