NCT01646060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

November 28, 2011

Last Update Submit

July 17, 2012

Conditions

Blood LossHealthy

Keywords

bloodlosshealthyvolumeTo evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.

Outcome Measures

Primary Outcomes (1)

  • Detect change in blood volume during blood draw

    15-30 minutes

Secondary Outcomes (1)

  • Detect insidious bleeding

    15-30 minutes

Study Arms (1)

Blood Draw

EXPERIMENTAL
Device: CM-1500

Interventions

CM-1500DEVICE

Blood Volume Monitor

Blood Draw

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Urgent Care

Aurora, Colorado, 80012, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nathaniel Moore, MD

    Rocky Mountain Urgent Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

July 20, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

US(1)