CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
CM-1500 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05012462
NCT05012462N/ACompleted
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Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Zynex Monitoring Solutions·interventional·Posted Aug 19, 2021·Updated Dec 6, 2024

In Brief

A clinical study evaluating CM-1500 and CM-1600 for Fluid Loss. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFluid Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 19, 2021
Enrollment StartSep 20, 2021
Primary CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.9 years ago

Interventions

CM-1500device

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-1600device

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.