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NCT04255108 · ClinicalTrials.gov registry record

Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output

A clinical trial, sponsored by Baxter Healthcare Corporation.

Completed
Registry status
50
Enrollment target

NCT04255108: Completed study, sponsored by Baxter Healthcare Corporation.

NCT04255108 is a clinical trial that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04255108 has completed, sponsored by Baxter Healthcare Corporation.

COMPLETED
Registry status
50 participants
Enrollment target

Study Summary

toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

Primary Outcome

The primary objective of this study is to validate stroke volume (the amount of blood pumped by the left ventrical of the heart in one contraction) measurements made using CoVa Patch to those made using a pulmonary artery catheter and the thermodilution method. Thermodilution requires a pulmonary artery catheter and are calculated by a monitoring system based on temperature changes in the heart when a cooler solution is injected into the right atrium via the proximal port of a pulmonary artery

Interventions

  • DEVICE Cova Patch

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2020-02-19
Est. Completion 2020-04-09
Baxter Healthcare Corporation

46 total trials

What the finished NCT04255108 record still lists

NCT04255108 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Cova Patch is the first listed.

NCT04255108 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04255108 about?

NCT04255108 is a clinical study titled "Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output". toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measuremen...

What is the current status of trial NCT04255108?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2020-02-19. Estimated completion is 2020-04-09.

What interventions are being tested in trial NCT04255108?

The interventions under investigation include: Cova Patch (DEVICE).

Who is sponsoring clinical trial NCT04255108?

This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04255108, the US trial registry maintained by the National Library of Medicine. NCT04255108 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.