Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-31 @ 12:07 AM
Study NCT ID:
NCT04031495
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-08-13', 'releaseDate': '2019-07-26'}], 'estimatedResultsFirstSubmitDate': '2019-07-26'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Central Vein Cannulation', 'timeFrame': '1 day', 'description': 'device enabled successful cannulation on the first pass showing feasibility to aid in cvcs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Central Vein Cannulation']}, 'descriptionModule': {'briefSummary': 'Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.', 'detailedDescription': 'Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04031495', 'briefTitle': 'Image Guidance for Improved Vessel Cannulation in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clear Guide Medical'}, 'officialTitle': 'Image Guidance for Improved Vessel Cannulation in Pediatric Patients', 'orgStudyIdInfo': {'id': '1R44HD096974-01', 'link': 'https://reporter.nih.gov/quickSearch/1R44HD096974-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'central vein cannulation', 'type': 'DEVICE', 'description': 'central vein cannulation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20910', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Karun Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's National Research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clear Guide Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's National Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-07-26', 'type': 'RELEASE'}, {'date': '2019-08-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Clear Guide Medical'}}}}