Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-31 @ 1:30 PM
Study NCT ID:
NCT03857204
Status:
UNKNOWN
Last Update Posted:
2019-12-05
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetus Weight Estimation by Ultrasound Data Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020567', 'term': 'Fetal Weight'}], 'ancestors': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'US scans for fetal weight assessment', 'timeFrame': '1 year', 'description': "1\\) To evaluate SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Weight']}, 'descriptionModule': {'briefSummary': "This research aims to allow deployment \\& optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women between 24+0 weeks and 41+6 weeks gestation.\n2. Women with a singleton viable pregnancy.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT03857204', 'briefTitle': 'Fetus Weight Estimation by Ultrasound Data Collection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Fetus Weight Estimation by Ultrasound Data Collection', 'orgStudyIdInfo': {'id': '0108-18-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'performing US scans for fetal weight assessment.', 'interventionNames': ['Device: SAMPL plain wave algorithm']}], 'interventions': [{'name': 'SAMPL plain wave algorithm', 'type': 'DEVICE', 'description': "SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.", 'armGroupLabels': ['performing US scans for fetal weight assessment.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hille Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Alon Shrim, MD', 'role': 'CONTACT', 'email': 'AlonS@hy.health.gov.il', 'phone': '+972-7744602'}, {'name': 'Osnat Palgi, BSc.', 'role': 'CONTACT', 'email': 'osnatp@hymc.gov.il'}], 'overallOfficials': [{'name': 'Alon Shrim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}