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Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

NCT ID: NCT05012462

Last Updated: 2024-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Fluid Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Apheresis Platelet Donation: CM-1500

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

Group Type EXPERIMENTAL

CM-1500

Intervention Type 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.

Apheresis Platelet Donation: CM-1600

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

Group Type EXPERIMENTAL

CM-1600

Intervention Type 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.

Interventions

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CM-1500

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.

Intervention Type DEVICE

CM-1600

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zynex Monitoring Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samantha Mack, MD

Role: PRINCIPAL_INVESTIGATOR

Vitalant Blood Donation

Locations

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Vitalant Blood Donation

Denver, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.zynexmonitoring.com

Related Info

Other Identifiers

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ZMS-1500-2021-Apheresis

Identifier Type: -

Identifier Source: org_study_id