Safety of the PET-512MC Transesophageal Transducer (TEE)
The objective of this Study is to demonstrate the safety of the PET-512MC 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-512MC Transesophageal Transducer (TEE)|
|Study Start Date:||August 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
patients requiring TEE procedure by their physician
The PET-512MC 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 purpose of this Study is to demonstrate the safety of the PET-512MC TEE transducer and gather feedback from the investigators related to the insertion of the transducer. The data will be used to determine the usability of the transducer in the clinical environment.
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Gregory B Clarke, MD||Christ Hospital|