Clinical trial NCT01268007: Heartbeat Sensitivity Calibration Using the ECG Accessory
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ECG Comparisons in Normal Healthy Subject
Lead sponsor: Cyberonics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-29
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal Healthy male

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of ECG measurements
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
References: