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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 Loss
NCT0183461220
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PHASE1COMPLETED
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Blood Loss
NCT0164606010
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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")
CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX1PHASE3CTX001
Incyte CorporationINCY1PHASE2Ruxolitinib
Molecular Partners AG Sponsored ADRMOLN1PHASE1MP0533 monotherapy, Part 1
Abbott LaboratoriesABT2N/AUndisclosed
Sangamo Therapeutics, Inc.SGMO1 - BIVV003, ST-400
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