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COMPLETED NA

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

NCT05012462 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DEVICE CM-1500
  • DEVICE CM-1600

Study Locations (1)

Colorado

  • Vitalant Blood Donation — Denver

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2021-09-20
Est. Completion 2022-12-20
Phase NA

Sponsor

Zynex Monitoring Solutions

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05012462

The ClinicalTrials.gov registry entry for NCT05012462 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zynex Monitoring Solutions, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Fluid Loss appearing as the primary indexed condition, and to 2 interventions — of which CM-1500 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05012462 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05012462 about?

NCT05012462 is a clinical study titled "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...

What is the current status of trial NCT05012462?

This trial is currently completed. It is a NA study. The enrollment target is 77 participants. The study started on 2021-09-20. Estimated completion is 2022-12-20.

What conditions does trial NCT05012462 study?

This clinical trial studies the following conditions: Fluid Loss. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05012462?

The interventions under investigation include: CM-1500 (DEVICE), CM-1600 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05012462?

This trial is sponsored by Zynex Monitoring Solutions, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05012462 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial