Safety of the PET-512MC Transesophageal Transducer

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.

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Key information

Conditions

Transesophageal Transducer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-512MC

Device

Transesophageal Transducer

Other names: TEE Transducer, TEE Probe

Sponsors and collaborators

Lead sponsor

Toshiba America Medical Systems, Inc.

Industry

Registry information

Official study title

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

Acronym: TEE

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Aug 23, 2010
Registry last updated: Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.