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

August 19, 2010 updated by: Toshiba America Medical Systems, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been scheduled for a TEE procedure by their physician.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TEE Procedure
Patients who have been scheduled for a TEE procedure by their physician
Device: PET-511BTM
Transesophageal Transducer
Other Names:
  • TEE Transducer
  • TEE Probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The TEE transducer passes safely into the esophagus.
Time Frame: during, 30 minutes, and 24 hours after the exam
during, 30 minutes, and 24 hours after the exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toshiba America Medical Systems, Inc.

Investigators

  • Principal Investigator: Gregory B. Clarke, M.D, The Christ Hospital
  • Principal Investigator: David Rubensen, M.D., Scripps Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (ESTIMATE)

October 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2010

Last Update Submitted That Met QC Criteria

August 19, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TEE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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