Patient Requiring TEE Procedure by Their PhysicianTEENCT00997568
Safety of the PET-511BTM Transesophageal Transducer
An observational study of Patient Requiring TEE Procedure by Their Physician, run by Toshiba America Medical Systems, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Requiring TEE Procedure by Their Physician
- What is being tested?
- PET-511BTM
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have been scheduled for a TEE procedure by their physician.
Who may be able to join
- Male and female patients between the ages of 20 and 80
- Informed consent understood and signed
- Compliance with post-treatment follow-up protocol requirements
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Scripps Health
La Jolla, California, 92037
About this study
Official title: Safety of the PET-511BTM Transesophageal Transducer (TEE)
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.
Read the detailed description
The PET-511BTM 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 objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.
- Being tested
- PET-511BTM
- Keywords
- transesophageal, transducer, TEE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-511BTMDevice
Also called TEE Transducer, TEE Probe
Transesophageal Transducer
| Study group | Role | What they receive |
|---|---|---|
| TEE Procedure | Patients who have been scheduled for a TEE procedure by their physician Receives: Device: PET-511BTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The TEE transducer passes safely into the esophagus.
Measured: during, 30 minutes, and 24 hours after the exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Requiring TEE Procedure by Their PhysicianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toshiba America Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregory B. Clarke, M.D, Principal investigator, The Christ HospitalDavid Rubensen, M.D., Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997568
- Sponsor's protocol ID
- TEE-001
- Acronym
- TEE
- Status last verified
- Aug 2010
- First submitted
- 15 Oct 2009
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the PET-511BTM Transesophageal Transducer (TEE)
- ClinicalTrials.gov ID
- NCT00997568
- Acronym / sponsor ID
- TEE / TEE-001
- Keywords
- transesophageal, transducer, TEE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Toshiba America Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The PET-511BTM 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 objective of the study is to demonstrate the safe use of the redesigned Toshibal TEE transducer for ease of passage and during transitioning into and down the esophagus to complete a normal TEE study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE Procedure | – | Device: PET-511BTMPatients who have been scheduled for a TEE procedure by their physician |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been scheduled for a TEE procedure by their physician.
Key inclusion criteria (3 listed)
- Male and female patients between the ages of 20 and 80
- Informed consent understood and signed
- Compliance with post-treatment follow-up protocol requirements
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-511BTMAlso: TEE Transducer, TEE ProbeTransesophageal Transducer | Device | TEE Procedure |
Primary outcome
The TEE transducer passes safely into the esophagus.
Time frame: during, 30 minutes, and 24 hours after the exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory B. Clarke, M.D principal investigator
The Christ Hospital
David Rubensen, M.D. principal investigator
Scripps Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Requiring TEE Procedure by Their Physician, run by Toshiba America Medical Systems, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The TEE transducer passes safely into the esophagus. (time frame: during, 30 minutes, and 24 hours after the exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.