Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-18 @ 10:58 PM
Study NCT ID:
NCT03066895
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BGS Neonatal Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-22', 'releaseDate': '2023-12-05'}], 'estimatedResultsFirstSubmitDate': '2023-12-05'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2017-02-17', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Up to 8 days', 'description': 'No device-attributable adverse events.'}], 'secondaryOutcomes': [{'measure': 'Pain Response', 'timeFrame': '2 minute intervals, starting at 15 minutes before procedure and continuing until 10 minutes post procedure', 'description': 'Pain level at specified study intervals measured on Neonatal Facial Coding System (NFCS) scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain From Heel Sticks']}, 'descriptionModule': {'briefSummary': 'This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStickâ˘; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically stable late preterm/term neonates with a gestational age at birth of \\> 35 weeks gestation at birth\n* Sex: male or female\n\nExclusion Criteria:\n\n* Congenital anomalies or conditions at birth impacting central nervous system functioning and autonomic measurements\n* Known risk for bleeding (i.e. Hemophilia, blood clotting or protein disorders)\n* Prolonged labor or delayed birth with evidence of perinatal depression (e.g. Infant Apgar scores below 5)\n* Identified maternal opiate dependency during pregnancy placing the infant at risk for opiate withdrawal, also known as neonatal abstinence syndrome (NAS)\n* Critical illness in the mother preventing the ability to obtain informed consent from parents'}, 'identificationModule': {'nctId': 'NCT03066895', 'briefTitle': 'BGS Neonatal Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actuated Medical, Inc.'}, 'officialTitle': 'Development and Testing of BabyGentleStick⢠Vibrated Needle System for Heel Lance- Neonatal Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY00006878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'BabyGentleStick', 'interventionNames': ['Device: BabyGentleStick']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'HMC Standard Lancing Device', 'interventionNames': ['Device: Standard Lancing Device']}], 'interventions': [{'name': 'BabyGentleStick', 'type': 'DEVICE', 'description': 'Experimental device.', 'armGroupLabels': ['Experimental']}, {'name': 'Standard Lancing Device', 'type': 'DEVICE', 'description': 'HMC standard of care.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Ryan Clement, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Actuated Medical, Inc.'}, {'name': 'Kim Doheny, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Pennsylvania State University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actuated Medical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-05', 'type': 'RELEASE'}, {'date': '2023-12-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Actuated Medical, Inc.'}}}}