Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Zynex Monitoring Solutions

Status: Completed

Conditions: Fluid Loss

Treatments: Device: CM-1500; Device: CM-1600

Study type: Interventional

Funder types: Industry

Identifiers

NCT05012462

ZMS-1500-2021-Apheresis

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Apheresis Platelet Donation: CM-1500

Experimental group

Description:

The subjects will be connected to the CM-1500 during apheresis platelet donation

Treatment:

Device: CM-1500

Apheresis Platelet Donation: CM-1600

Experimental group

Description:

The subjects will be connected to the CM-1600 during apheresis platelet donation

Treatment:

Device: CM-1600