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Safety of the PET-512MC Transesophageal Transducer

NCT ID: NCT01186380

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Transesophageal Transducer

Keywords

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TEE Transesophageal Transducer Esophagus Ease of passage and during transitioning into and down the esophagus to complete a normal TEE study

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TEE Procedure

patients requiring TEE procedure by their physician

PET-512MC

Intervention Type DEVICE

Transesophageal Transducer

Interventions

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PET-512MC

Transesophageal Transducer

Intervention Type DEVICE

Other Intervention Names

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TEE Transducer TEE Probe

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toshiba America Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Toshiba America Medical Systems, Inc.

Principal Investigators

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Gregory B Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Christ Hospital

Locations

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The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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TEE-002

Identifier Type: -

Identifier Source: org_study_id