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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186380
First Posted: August 23, 2010
Last Update Posted: November 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Toshiba America Medical Systems, Inc.
  Purpose
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.

Condition Intervention
Transesophageal Transducer Device: PET-512MC

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of the PET-512MC Transesophageal Transducer (TEE)

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

Enrollment: 50
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TEE Procedure
patients requiring TEE procedure by their physician
Device: PET-512MC
Transesophageal Transducer
Other Names:
  • TEE Transducer
  • TEE Probe

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients ages 18 and above
Criteria

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

  Contacts and Locations
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): NCT01186380


Locations
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, MD Christ Hospital
  More Information

Responsible Party: Terry Schultz, Manager Regulatory Affairs, Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01186380     History of Changes
Other Study ID Numbers: TEE-002
First Submitted: August 19, 2010
First Posted: August 23, 2010
Last Update Posted: November 23, 2010
Last Verified: November 2010

Keywords provided by Toshiba America Medical Systems, Inc.:
TEE
Transesophageal
Transducer
Esophagus
Ease of passage and during transitioning into and down the esophagus to complete a normal TEE study