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

Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01834612

Enrollment

Registered

2013-04-18

Start date

2013-01-07

Completion date

2013-03-11

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss

Keywords

blood loss, hemorrhage, hemorrhagic shcok

Brief summary

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

Interventions

DEVICECM1500

blood volume monitor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026