NCT01186380

Safety of the PET-512MC Transesophageal Transducer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Toshiba America Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Transesophageal Transducer

Interventions

Type	Name	Description
DEVICE	PET-512MC	Transesophageal Transducer

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-08-23
• Last updated: 2010-11-23

Locations

1 site across 1 country: United States