Safety of the PET-512MC Transesophageal Transducer (TEE)

Toshiba Medical Systems

Status: Completed

Conditions: Transesophageal Transducer

Treatments: Device: PET-512MC

Study type: Observational

Funder types: Industry

Identifiers

NCT01186380

TEE-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult male and female patients ages 18 and above who have been scheduled for a TEE procedure by their physician
• Informed consent understood and signed
• Compliance with post-treatment and follow-up protocol requirements

Exclusion Criteria

• None

Trial design

50 participants in 1 patient group

TEE Procedure

Description:

patients requiring TEE procedure by their physician

Treatment:

Device: PET-512MC