NCT00997568

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
Last Updated

August 20, 2010

Status Verified

August 1, 2010

First QC Date

October 15, 2009

Last Update Submit

August 19, 2010

Conditions

Patient Requiring TEE Procedure by Their Physician

Keywords

transesophagealtransducerTEE

Outcome Measures

Primary Outcomes (1)

  • The TEE transducer passes safely into the esophagus.

    during, 30 minutes, and 24 hours after the exam

Study Arms (1)

TEE Procedure

Patients who have been scheduled for a TEE procedure by their physician

Device: PET-511BTM

Interventions

PET-511BTMDEVICE

Transesophageal Transducer

Also known as: TEE Transducer, TEE Probe
TEE Procedure

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been scheduled for a TEE procedure by their physician.

You may qualify if:

  • Male and female patients between the ages of 20 and 80
  • Informed consent understood and signed
  • Compliance with post-treatment follow-up protocol requirements

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scripps Health

La Jolla, California, 92037, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Study Officials

  • Gregory B. Clarke, M.D

    The Christ Hospital

    PRINCIPAL INVESTIGATOR

  • David Rubensen, M.D.

    Scripps Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 19, 2009

Study Start

October 1, 2009

Last Updated

August 20, 2010

Record last verified: 2010-08

Locations

US(2)