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CM-1500

Phase 1

Blood Loss | Unknown | Other |Zynex, Inc.|Last Updated: Jul 21, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

CM-1500 · 2 trials · 2 indications

Phase 1 2
NCT01834612Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood DrawBlood Loss
COMPLETED20 Analytics
NCT01646060Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood DrawBlood Loss
COMPLETED10 Analytics
PHASE1COMPLETED
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
Blood LossUnlock trial analytics
PHASE1COMPLETED
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Blood LossUnlock trial analytics

Study Endpoints

Primary Endpoints

Detect change in blood volume by non-invasive monitoring during whole blood draw
4 months
Detect change in blood volume during blood draw
15-30 minutes

Secondary Endpoints

Detect insidious bleeding
15-30 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Blood drawACTIVE_COMPARATORCM1500 with blood draw
No blood drawSHAM_COMPARATORCM 1500 with no blood draw

Interventions

NameTypeDescription
CM1500DEVICEblood volume monitor
CM-1500DEVICEBlood Volume Monitor
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Competitive Landscape -Blood Disorders 6 trials (matched to "Blood Loss")

Frequently asked questions about CM-1500

What is CM-1500 used for?

CM-1500 is an investigational device being developed for blood loss monitoring. It is designed to evaluate blood volume changes during blood draws in healthy subjects. The device is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes CM-1500?

CM-1500 is being developed by Zynex, Inc., a company traded on the NASDAQ under the ticker ZYXI. The company is conducting clinical trials to evaluate the device's performance in monitoring blood loss.

What phase is CM-1500 in?

CM-1500 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The device is investigational and has not received regulatory approval for commercial use.

What clinical trials is CM-1500 in?

CM-1500 has been evaluated in two completed Phase 1 trials: NCT01646060, which enrolled 10 healthy male subjects, and NCT01834612, which enrolled 20 healthy adult volunteers. Both studies were conducted in the United States and involved blood draws.

Is CM-1500 the same as the Zynex Blood Volume Monitor?

CM-1500 is the device evaluated in clinical trials under the name Zynex Blood Volume Monitor. The trials NCT01646060 and NCT01834612 both reference the CM-1500 in their titles, indicating they refer to the same device.