Trial record 9 of 2554 for:    Open Studies | "Blood"

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

This study is currently recruiting participants.
Verified April 2013 by Zynex Monitoring Solutions
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
  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
Endpoint Classification: Efficacy Study
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

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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Zynex Monitoring Solutions:
blood loss, hemorrhage, hemorrhagic shcok

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014