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

This study has been completed.
Sponsor:
Information provided by:
Toshiba America Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01186380
First received: August 19, 2010
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013