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

Toshiba Medical Systems

Status: Completed

Conditions: Patient Requiring TEE Procedure by Their Physician

Treatments: Device: PET-511BTM

Study type: Observational

Funder types: Industry

Identifiers

NCT00997568

TEE-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

TEE Procedure

Description:

Patients who have been scheduled for a TEE procedure by their physician

Treatment:

Device: PET-511BTM