NCT01846195

Brief Summary

Non-invasive monitoring to measure changes in blood volume.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

November 9, 2022

Completed
Last Updated

November 9, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

March 13, 2013

Results QC Date

August 3, 2022

Last Update Submit

October 13, 2022

Conditions

Blood Loss

Keywords

blood loss

Outcome Measures

Primary Outcomes (1)

  • Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw

    Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

    At study completion (completion of blood draw)

Study Arms (2)

no blood draw

SHAM COMPARATOR

CM 1500 with no blood draw

Device: CM 1500

blood draw

ACTIVE COMPARATOR

CM 1500 with blood draw

Device: CM 1500

Interventions

CM 1500DEVICE
blood drawno blood draw

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Between 18-35 years of age
  • Weight between 130-200 pounds

You may not qualify if:

  • Known cardiac disease
  • Recent caffeine intake
  • Tobacco use in the (4) hours prior to screening
  • Infection
  • Pregnancy
  • Hemoglobin \<13.5 g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Premier Research Group

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Donald Gregg
Organization
Zynex Monitoring Solutions
dgregg@zynex.com
1-800-495-6670

Study Officials

  • John Ziegler, MD

    Premier Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

May 3, 2013

Study Start

June 6, 2012

Primary Completion

March 20, 2013

Study Completion

March 20, 2013

Last Updated

November 9, 2022

Results First Posted

November 9, 2022

Record last verified: 2022-10

Locations

US(1)