Safety of the PET-512MC Transesophageal Transducer

Completed

• Conditions: Transesophageal Transducer
• Interventions: Device: PET-512MC

• Registration Number: NCT01186380
• Lead Sponsor: Toshiba America Medical Systems, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-19
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEE Procedure	PET-512MC	patients requiring TEE procedure by their physician

Trial Locations

Locations (1)

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States