Safety of the PET-511BTM Transesophageal Transducer
- Conditions
- Patient Requiring TEE Procedure by Their Physician
- Interventions
- Device: PET-511BTM
- Registration Number
- NCT00997568
- Lead Sponsor
- Toshiba America Medical Systems, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Male and female patients between the ages of 20 and 80
- Informed consent understood and signed
- Compliance with post-treatment follow-up protocol requirements
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TEE Procedure PET-511BTM Patients who have been scheduled for a TEE procedure by their physician
- Primary Outcome Measures
Name Time Method The TEE transducer passes safely into the esophagus. during, 30 minutes, and 24 hours after the exam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Scripps Health
🇺🇸La Jolla, California, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States