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NCT01268007 · ClinicalTrials.gov registry record

Heartbeat Sensitivity Calibration Using the ECG Accessory

A clinical trial, sponsored by Cyberonics.

Completed
Registry status
1
Enrollment target

NCT01268007: Completed study, sponsored by Cyberonics.

NCT01268007 is a clinical trial that has completed, run by Cyberonics. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01268007 has completed, sponsored by Cyberonics.

COMPLETED
Registry status
1 participants
Enrollment target

Study Summary

This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG recordings collected by an investigational device for comparison with conventional ECG recordings. This data will be used to validate a new device under development.

Primary Outcome

No specific effectiveness outcomes or calculations are planned for this non-interventional study. The sponsor will use the ECG data collected during this study as a comparison of the subject's actual ECG waveforms obtained through standard ECG connections to the ECG Accessory transmitted heart beat detection signals from the Model 106 Generator to the ECG monitor.

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2010-12
Est. Completion 2010-12
Cyberonics

15 total trials

What the finished NCT01268007 record still lists

NCT01268007 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01268007 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01268007 about?

NCT01268007 is a clinical study titled "Heartbeat Sensitivity Calibration Using the ECG Accessory". This is an observational, un-blinded, non-significant risk, non-interventional study designed to collect ECG data on at least one subject out of a pool of up to three (3) healthy male subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG recordings collected by ...

What is the current status of trial NCT01268007?

This trial is currently completed. The enrollment target is 1 participants. The study started on 2010-12. Estimated completion is 2010-12.

Who is sponsoring clinical trial NCT01268007?

This trial is sponsored by Cyberonics, which has 15 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01268007, the US trial registry maintained by the National Library of Medicine. NCT01268007 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.