Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

NCT05012462 | Completed Results FDA Device

• 1 other identifier: ZMS-1500-2021-Apheresis
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluid Loss

Outcome Measures

Primary Outcomes (1)

• Characterize Changes in the Relative Index During an Apheresis Procedure

  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.

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

Study Arms (2)

Apheresis Platelet Donation: CM-1500

EXPERIMENTAL

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

Device: CM-1500

Apheresis Platelet Donation: CM-1600

EXPERIMENTAL

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

Device: CM-1600

Interventions

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.

Apheresis Platelet Donation: CM-1500

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.

Apheresis Platelet Donation: CM-1600

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent
• Ability and willingness to comply with the study procedures and duration requirements
• years of age or older
• Consented to undergo an apheresis procedure with an automated blood component device

You may not qualify if:

• Females who are pregnant or breastfeeding
• Undergone an amputation of the left upper extremity
• Diagnosed with dextrocardia
• Subjects who have a pacemaker

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead

Study Sites (1)

Vitalant Blood Donation

Denver, Colorado, 80230, United States

Location

Related Links

• Related Info

Results Point of Contact

• Title: ZMS Clinical
• Organization: Zynex Monitoring Solutions

clinical@zynexmonitoring.com

800-495-6670

Study Officials

• Samantha Mack, MD

  Vitalant Blood Donation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 19, 2021
• Study Start: September 20, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)