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COMPLETED

Reference Range Study for the Quantra QStat System

NCT04219371 · View on ClinicalTrials.gov ↗

Study Summary

The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Quantra System

Study Locations (3)

Georgia

  • WR-Mount Vernon Clinical Research, LLC — Sandy Springs

North Carolina

  • M3 Wake Research — Raleigh

Tennessee

  • WR-ClinSearch, LLC — Chattanooga

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2020-01-07
Est. Completion 2020-06-30

Sponsor

HemoSonics

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04219371

The ClinicalTrials.gov registry entry for NCT04219371 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HemoSonics, which has 6 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 Coagulation Disorder appearing as the primary indexed condition, and to 1 intervention — of which Quantra System 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: NCT04219371 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, North Carolina, Tennessee. 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 NCT04219371 about?

NCT04219371 is a clinical study titled "Reference Range Study for the Quantra QStat System". The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

What is the current status of trial NCT04219371?

This trial is currently completed. The enrollment target is 140 participants. The study started on 2020-01-07. Estimated completion is 2020-06-30.

What conditions does trial NCT04219371 study?

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

What interventions are being tested in trial NCT04219371?

The interventions under investigation include: Quantra System (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04219371?

This trial is sponsored by HemoSonics, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04219371 being conducted?

This trial has 3 study locations across Georgia, North Carolina, Tennessee. 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