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).

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.

Study Overview

• Status: Completed
• Conditions: ECG Comparisons in Normal Healthy Subject

Detailed Description

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). If acceptable data is acquired from one (1) subject the remaining subjects will not be entered into the study. Three (3) to six (6) researchers will record data, but all direct contact with the subject will be done by the study coordinator or principal investigator (PI).

The purpose of this study is to validate a Heartbeat Sensitivity calibration process utilizing the Cyberonics ECG Accessory. The non-invasive, passive collection of ECG signals from a resting healthy subject will be used to validate the use of the ECG Accessory with the Model 201 Programming Wand, Model 250 VNS Programming Software Version 9.0, Model 106 Generator, and ECG monitor (DRE True ECG-12), as well as the associated Instructions for Use. The data generated from this exercise will be used in future clinical trials utilizing this device.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Normal Healthy male

Description

Inclusion Criteria:

• 1. Patients must be 18 years or older, male, and of any race.
• 2. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
• 3. Patient must be willing and able to complete informed consent and HIPAA authorization.

Exclusion Criteria:

• 1. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
• 2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.
• 3. Subjects with major health condition that in the investigator's judgment would prevent the subject's successful completion of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Normal ECG measurements; Observational, un-blinded, non-interventional study designed to collect ECG data on at least one (1) male patient in an outpatient setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of ECG measurements	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.	8 hours

Collaborators and Investigators

• Sponsor: Cyberonics, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (ESTIMATE): December 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 24, 2011
• Last Update Submitted That Met QC Criteria: January 20, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: E-46