NCT00997568

Safety of the PET-511BTM Transesophageal Transducer

Safety of the PET-511BTM Transesophageal Transducer (TEE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Toshiba America Medical Systems, Inc. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Patient Requiring TEE Procedure by Their Physician

Interventions

Type	Name	Description
DEVICE	PET-511BTM	Transesophageal Transducer

Timeline

• Start date: 2009-10-01
• First posted: 2009-10-19
• Last updated: 2010-08-20

Locations

2 sites across 1 country: United States