Evaluation of the Zynex Blood Volume Monitor in Healthy A... | NCT01834612

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

NCT01834612

Sponsor

Zynex Monitoring Solutions

Status

Completed

Last Update Posted

Jul 21, 2021Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Blood Loss

Interventions

CM1500

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2013Actual

Primary Completion Date

Mar 11, 2013Actual

Completion Date

Mar 11, 2013Actual

First Submitted Date

Apr 15, 2013

First Submission Date that Met QC Criteria

Apr 15, 2013

First Posted Date

Apr 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2021

Last Update Posted Date

Jul 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood draw	Active Comparator	CM1500 with blood draw	Device: CM1500
No blood draw	Sham Comparator	CM 1500 with no blood draw	Device: CM1500

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM1500	Device	blood volume monitor	Blood draw No blood draw

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detect change in blood volume by non-invasive monitoring during whole blood draw		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chris Galloway, MD	Davita Clinical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DaVita Clinical Research		Lakewood	Colorado	80228	United States

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided