Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

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.

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Key information

Conditions

Fluid Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitalant Blood Donation

Denver, Colorado, 80230, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM-1500

Device

The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.

CM-1600

Device

The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.

Primary outcomes

Characterize Changes in the Relative Index During an Apheresis Procedure

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

The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 19, 2021
Registry last updated: Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed