Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT00997568
Status:
COMPLETED
Last Update Posted:
2010-08-20
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of the PET-511BTM Transesophageal Transducer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-19', 'studyFirstSubmitDate': '2009-10-15', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The TEE transducer passes safely into the esophagus.', 'timeFrame': 'during, 30 minutes, and 24 hours after the exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transesophageal', 'transducer', 'TEE'], 'conditions': ['Patient Requiring TEE Procedure by Their Physician']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been scheduled for a TEE procedure by their physician.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients between the ages of 20 and 80\n* Informed consent understood and signed\n* Compliance with post-treatment follow-up protocol requirements\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00997568', 'acronym': 'TEE', 'briefTitle': 'Safety of the PET-511BTM Transesophageal Transducer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toshiba America Medical Systems, Inc.'}, 'officialTitle': 'Safety of the PET-511BTM Transesophageal Transducer (TEE)', 'orgStudyIdInfo': {'id': 'TEE-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TEE Procedure', 'description': 'Patients who have been scheduled for a TEE procedure by their physician', 'interventionNames': ['Device: PET-511BTM']}], 'interventions': [{'name': 'PET-511BTM', 'type': 'DEVICE', 'otherNames': ['TEE Transducer', 'TEE Probe'], 'description': 'Transesophageal Transducer', 'armGroupLabels': ['TEE Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Gregory B. Clarke, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Christ Hospital'}, {'name': 'David Rubensen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toshiba America Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Terry Schultz, Manager Regulatory Affairs', 'oldOrganization': 'Toshiba America Medical Systems, Inc.'}}}}