CompletedNot Applicable

Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

United States351 participantsStarted 2022-09-14

Plain-language summary

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Ability to provide written consent * Ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * Consented and eligible to undergo a single unit whole blood donation Exclusion Criteria: * Females who are pregnant or breastfeeding * Undergone an amputation of any upper extremity * Diagnosed with dextrocardia * Subjects who have a pacemaker * Subjects with body hair density which prevents adequate application of device electrodes

What they're measuring

Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)

Timeframe: Recovery period following donation (10 minutes)

Trial details

NCT IDNCT05463198

SponsorZynex Monitoring Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-27

Results submitted2024-06-20

View on ClinicalTrials.gov More Fluid Loss trials