Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
Study NCT ID:
NCT05142566
Status:
TERMINATED
Last Update Posted:
2023-07-27
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MANTA Ultrasound Closure Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'darra.bigelow@teleflex.com', 'phone': '610-331-7299', 'title': 'Darra Bigelow, Sr. Manager, Clinical Operations', 'organization': 'Essential Medical LLC (a subsidary of Teleflex, Inc.)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study (ST-3370) was terminated early primarily for business reasons. The sponsor recognized that the conditions for widespread adoption of ultrasound-based MANTA deployment do not presently exist. As a result of this finding and the likelihood that the study would not provide sufficient data to support a future labeling change, the sponsor decided to terminate the study.'}}, 'adverseEventsModule': {'timeFrame': 'Index procedure up to 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Access Site Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema in left hand', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Transient Ischemic Attack (TIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'adapted from VARC-2 Criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '.42', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '9.87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure', 'description': 'The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Technical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Ambulation Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure admission', 'description': 'If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.93', 'groupId': 'OG000', 'lowerLimit': '4.21', 'upperLimit': '119.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During procedure admission', 'description': 'The elapsed time between VCD deployment and when ambulation is achieved.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'Time to Hemostasis ≤10 minutes and no VACR-2 Major complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '1.62'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the procedure', 'description': 'Elapsed time from initial skin break to time when the post-deployment angiogram is completed.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 days', 'description': 'adapted from VARC-2 Criteria', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'one subject was treated by a physician who was not officially trained and signed off on the protocol or device.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.\n\nMANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.06', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-03', 'size': 670793, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-08T11:53', 'hasProtocol': True}, {'date': '2022-02-02', 'size': 310935, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-08T11:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Ineffective enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2021-11-10', 'resultsFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2021-11-19', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-06', 'studyFirstPostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication', 'timeFrame': 'within 30 days', 'description': 'adapted from VARC-2 Criteria'}], 'secondaryOutcomes': [{'measure': 'Time to Hemostasis', 'timeFrame': 'During the procedure', 'description': 'The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.'}, {'measure': 'Number of Patients With Technical Success', 'timeFrame': 'within 30 days', 'description': 'Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.'}, {'measure': 'Number of Subjects With Ambulation Success', 'timeFrame': 'During procedure admission', 'description': 'If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.'}, {'measure': 'Time to Ambulation', 'timeFrame': 'During procedure admission', 'description': 'The elapsed time between VCD deployment and when ambulation is achieved.'}, {'measure': 'Treatment Success', 'timeFrame': 'within 30 days', 'description': 'Time to Hemostasis ≤10 minutes and no VACR-2 Major complications'}, {'measure': 'Procedure Time', 'timeFrame': 'During the procedure', 'description': 'Elapsed time from initial skin break to time when the post-deployment angiogram is completed.'}, {'measure': 'Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication', 'timeFrame': 'within 30 days', 'description': 'adapted from VARC-2 Criteria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['MANTA', 'Arterial Closure Device', 'Ultrasound Closure', 'Large Bore Closure Device'], 'conditions': ['Femoral Arteriotomy Closure']}, 'descriptionModule': {'briefSummary': 'Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.', 'detailedDescription': 'The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.\n\nThis study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach\n* Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD\n* Understand and sign the study specific written informed consent form and PHI authorization\n* Able and willing to fulfill the follow-up requirements\n\nExclusion Criteria:\n\n* Patients known to be pregnant or lactating\n* Patients who have a systemic infection or a local infection at or near the access site\n* Patients with significant anemia (hemoglobin ≤10 g/DL)\n* Patients who are morbidly obese or cachectic (BMI \\>40 or \\<20kg/m2)\n* Patients with a known bleeding disorder including thrombocytopenia (platelet count \\<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease\n* Patients with allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel\n* Patients with a femoral artery puncture in target groin within the prior 30 days, prior vascular closure device placement in the target common femoral artery within 3 months, or any prior target femoral artery access-related complication\n* Patients who have undergone use of an intra-aortic balloon pump (IABP) through the arterial access site within 30 days prior to the baseline evaluation.\n* Patients who have a Common Femoral Artery (CFA) with visible calcium and/or tortuosity, as determined by baseline CTA, precluding safe access and likely to interact with large bore access site arteriotomy, determined by investigator.\n* Patients with previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area\n* Patients in whom oral anticoagulation therapy cannot be stopped for the peri procedural period or patients with INR \\>1.8 at the time of the procedure\n* Patients who are unable to ambulate at least 6 meters without assistance at baseline\n* Patients with renal insufficiency (serum creatinine \\>2.5 mg/dl) or on dialysis therapy\n* Patients with existing nerve damage in the ipsilateral leg\n* Patients with a further planned endovascular procedure within the next 30 days\n* Patients who have already participated in this IDE study\n* Patients who are currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period or patient currently participating in another clinical study likely to influence hemostasis and vascular complications\n* Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease\n* Patients who have a common femoral artery \\<5mm in diameter for the 14F MANTA VCD or \\<6 mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a vessel diameter \\<5mm in diameter for the 14F MANTA VCD or \\<6 mm in diameter for the 18F MANTA VCD, or \\> 50% diameter femoral or iliac artery stenosis\n* Patients in whom, during initial access of the artery, arteriotomy and surrounding anatomy cannot be visualized and identified clearly under U/S imaging and/or if the vertical depth from the surface of the skin to target area of the common femoral artery measures greater than 6cm'}, 'identificationModule': {'nctId': 'NCT05142566', 'acronym': 'MANTA ULTRA', 'briefTitle': 'MANTA Ultrasound Closure Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Essential Medical, Inc.'}, 'officialTitle': 'Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study', 'orgStudyIdInfo': {'id': 'ST-3370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound Closure', 'description': 'Open label, single arm study using ultrasound guidance during MANTA device deployment.', 'interventionNames': ['Device: MANTA Vascular Closure Device']}], 'interventions': [{'name': 'MANTA Vascular Closure Device', 'type': 'DEVICE', 'description': 'Evaluate the safety of ultrasound guided deployment of MANTA VCD.', 'armGroupLabels': ['Ultrasound Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '78665', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '22191', 'city': 'Woodbridge', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Northern Virginia Medical Center', 'geoPoint': {'lat': 38.65817, 'lon': -77.2497}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Health', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'David Wood', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vancouver General Hospital'}, {'name': 'Vijay Iyer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data obtained will be used, without mentioning Subject PHI, to assess the results of the research, and the data could be used in the future with regard to this study or other studies. The data can be passed on to the health authorities for the purposes of registering the medical device.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Essential Medical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}