Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT03750266
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2018-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Animation and Models to Aid Management of Fetal CDH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065630', 'term': 'Hernias, Diaphragmatic, Congenital'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient demographics', 'timeFrame': 'Baseline', 'description': 'Gestational age at time of scan and health outcomes from patient notes. This will be used to assess the accuracy of the 3D models developed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Diaphragmatic Hernia']}, 'descriptionModule': {'briefSummary': "We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH. This will both help the parents see what the problem is and also allow the surgeons, who will operate on the baby once it has been born, to see the size of the hole and what organs are in the wrong place."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study', 'genderDescription': 'Pregnant women whose fetus had a CDH and are referred to MRI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Target Population: pregnancy women attending Jessop Wing Fetal medicine unit.\n* Accessible population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI.\n* Study population: Pregnant women attending Jessop Wing Fetal medicine unit. Whose fetus had a CDH and are referred to MRI and agree to take part in the study.\n\nExclusion Criteria:\n\n* Not able to give informed consent due to any reason including poor understanding of English\n* Under 18 years of age.\n* Unable to complete the fetal MRI process due to either metal implants or claustrophobia.'}, 'identificationModule': {'nctId': 'NCT03750266', 'briefTitle': '3D Animation and Models to Aid Management of Fetal CDH', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'The Role of 3D Images and Models to Aid Management of Cases of Congenital Diaphragmatic Hernia Diagnosed in the Antenatal Period. Consecutive Patients Studied From Diagnosis to Post Operative Period.', 'orgStudyIdInfo': {'id': 'STH19783'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital Diaphragmatic Hernia referred for fetal MRA', 'interventionNames': ['Other: No intervention data collected through routine scans']}], 'interventions': [{'name': 'No intervention data collected through routine scans', 'type': 'OTHER', 'description': "No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.", 'armGroupLabels': ['Congenital Diaphragmatic Hernia referred for fetal MRA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elspeth Whitby', 'role': 'CONTACT', 'email': 'e.whitby@sheffield.ac.uk', 'phone': '0114 2261081'}], 'facility': 'Jessop Wing Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}