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

Phase 1

Completed

• Conditions: Blood Loss
• Interventions: Device: CM1500

• Registration Number: NCT01834612
• Lead Sponsor: Zynex Monitoring Solutions

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-07
• Primary Completion: 2013-03-11
• Study Completion: 2013-03-11
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No blood draw	CM1500	CM 1500 with no blood draw
Blood draw	CM1500	CM1500 with blood draw

Primary Outcome Measures

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

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Lakewood, Colorado, United States