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

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ClinicalTrials.gov Identifier: NCT00997568
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : August 20, 2010
Sponsor:
Information provided by:
Toshiba America Medical Systems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Patient Requiring TEE Procedure by Their Physician Device: PET-511BTM

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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of the PET-511BTM Transesophageal Transducer (TEE)
Study Start Date : October 2009

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




Primary Outcome Measures :
  1. The TEE transducer passes safely into the esophagus. [ Time Frame: during, 30 minutes, and 24 hours after the exam ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been scheduled for a TEE procedure by their physician.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997568


Locations
United States, California
Scripps Health
La Jolla, California, United States, 92037
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Toshiba America Medical Systems, Inc.
Investigators
Principal Investigator: Gregory B. Clarke, M.D The Christ Hospital
Principal Investigator: David Rubensen, M.D. Scripps Health

Responsible Party: Terry Schultz, Manager Regulatory Affairs, Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT00997568     History of Changes
Other Study ID Numbers: TEE-001
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010

Keywords provided by Toshiba America Medical Systems, Inc.:
transesophageal
transducer
TEE