Patient Requiring TEE Procedure by Their Physician
Conditions
Keywords
transesophageal, transducer, TEE
Brief summary
The purpose of this study is to demonstrate the safety of the redesigned transesophageal echocardiogram (TEE) transducer as it is inserted and transitioned into the esophagus through the mouth.
Detailed description
The PET-511BTM is a multiplane transesophageal transducer designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall. The objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.
Interventions
DEVICEPET-511BTM
Transesophageal Transducer
Sponsors
Toshiba America Medical Systems, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female patients between the ages of 20 and 80 * Informed consent understood and signed * Compliance with post-treatment follow-up protocol requirements
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The TEE transducer passes safely into the esophagus. | during, 30 minutes, and 24 hours after the exam |
Countries
United States
Outcome results
None listed