CompletedNot Applicable

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

United States77 participantsStarted 2021-09-20

Plain-language summary

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to provide written informed consent * Ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * Consented to undergo an apheresis procedure with an automated blood component device Exclusion Criteria: * Females who are pregnant or breastfeeding * Undergone an amputation of the left upper extremity * Diagnosed with dextrocardia * Subjects who have a pacemaker

What they're measuring

Characterize Changes in the Relative Index During an Apheresis Procedure

Timeframe: Duration of apheresis procedure (e.g., 2 - 3hrs)

Trial details

NCT IDNCT05012462

SponsorZynex Monitoring Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-20

Results submitted2024-06-20

View on ClinicalTrials.gov More Fluid Loss trials