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Safety of the PET-512MC Transesophageal Transducer

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01186380
Acronym
TEE
Enrollment
50
Registered
2010-08-23
Start date
2010-08-31
Completion date
2010-11-30
Last updated
2010-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transesophageal Transducer

Keywords

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

Brief summary

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

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.

Interventions

DEVICEPET-512MC

Transesophageal Transducer

Sponsors

Toshiba America Medical Systems, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026