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OpenTrials
Completed

NCT Number: NCT00997568

Safety of the PET-511BTM Transesophageal Transducer

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.

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Key information

Conditions

Patient Requiring TEE Procedure by Their Physician

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health, La Jolla, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

PET-511BTM

Device

Transesophageal Transducer

Other names: TEE Transducer, TEE Probe

Primary outcomes

  1. The TEE transducer passes safely into the esophagus.

    Time frame: during, 30 minutes, and 24 hours after the exam

Sponsors and collaborators

Lead sponsor

Toshiba America Medical Systems, Inc.

Industry

Registry information

Official study title

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

Acronym: TEE

Important dates

Study start
2009
First posted
Oct 19, 2009
Registry last updated
Aug 20, 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.