Safety of the PET-511BTM Transesophageal Transducer (TEE)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Safety of the PET-511BTM Transesophageal Transducer (TEE)|
- The TEE transducer passes safely into the esophagus. [ Time Frame: during, 30 minutes, and 24 hours after the exam ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
Patients who have been scheduled for a TEE procedure by their physician
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997568
|United States, California|
|La Jolla, California, United States, 92037|
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Gregory B. Clarke, M.D||The Christ Hospital|
|Principal Investigator:||David Rubensen, M.D.||Scripps Health|