N/A N=77 Diagnostic

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Fluid Loss

Bottom Line

View on ClinicalTrials.gov: NCT05012462 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Characterize Changes in the Relative Index During an Apheresis Procedure — 94.9; 99.3 Relative Index

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CM-1500 (Device); CM-1600 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zynex Monitoring Solutions
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Characterize Changes in the Relative Index During an Apheresis Procedure	94.9; 99.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05012462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.