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

This study has been completed.
Sponsor:
Information provided by:
Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00997568
First received: October 15, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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 Intervention
Patient Requiring TEE Procedure by Their Physician
Device: PET-511BTM

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of the PET-511BTM Transesophageal Transducer (TEE)

Further study details as provided by Toshiba America Medical Systems, Inc.:

Primary Outcome Measures:
  • The TEE transducer passes safely into the esophagus. [ Time Frame: during, 30 minutes, and 24 hours after the exam ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2009
Groups/Cohorts Assigned Interventions
TEE Procedure
Patients who have been scheduled for a TEE procedure by their physician
Device: PET-511BTM
Transesophageal Transducer
Other Names:
  • TEE Transducer
  • PET-511BTM
  • TEE Probe

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 15, 2009
Last Updated: August 19, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014