Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT04813367
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Twisted Fallopian Tubes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fallopian tube Surgery results', 'timeFrame': 'Evaluation 10 years after surgery', 'description': 'Evaluation of twisted fallopian surgery interest on then long terms, define as percentage of patients going through surgical revision'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Twisted Fallopian Tube'], 'conditions': ['Twisted Fallopian Tube']}, 'descriptionModule': {'briefSummary': 'Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.\n\nBecause of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Girl younger than 18 with isolated tubal torsion. Girl above 18 and tubal torsion associated with ovary torsion are excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient younger then 18 going through surgery for twisted fallopian tubes\n\nExclusion Criteria:\n\n* Girl above 18 and tubal torsion associated with ovary torsion'}, 'identificationModule': {'nctId': 'NCT04813367', 'acronym': 'Tubes', 'briefTitle': 'Twisted Fallopian Tubes', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study', 'orgStudyIdInfo': {'id': '69HCL21_0239'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Twisted fallopian tubes cohort', 'description': 'Description of girls who went through surgery for twisted fallopian tubes', 'interventionNames': ['Procedure: Surgery of twisted fallopian tubes']}], 'interventions': [{'name': 'Surgery of twisted fallopian tubes', 'type': 'PROCEDURE', 'description': 'Patients diagnosed with twisted fallopian tube go through surgery.', 'armGroupLabels': ['Twisted fallopian tubes cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Marseille', 'country': 'France', 'facility': 'APHM, Hôpital La Timone Enfants et Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital NECKER Enfant Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '91016', 'city': 'Erice', 'country': 'Italy', 'facility': 'ASP Trapani - presidio ospedaliero "S. Antonio Abate', 'geoPoint': {'lat': 38.03785, 'lon': 12.58778}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'AOU Siena, Ospedale le Scotte', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale infantile Regina Margherita', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Institute for Maternal and Child Health - IRCCS "Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Institute for Maternal and Child Health IRCCS G. Gaslini, Genova', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Hôtel-Dieu de France Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Hospital d Urgences pour les enfants', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': "Ege University Faculty of Medicine Children's Hospital", 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Daniel GORDUZA, Dr', 'role': 'CONTACT', 'email': 'Daniel.gorduza@chu-lyon.fr', 'phone': '4 72 35 52 27', 'phoneExt': '+33'}, {'name': 'Julien BERTHILLER, Dr', 'role': 'CONTACT', 'email': 'julien.berthiller@chu-lyon.fr', 'phone': '4 27 85 63 01', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}