Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT07106502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Learning to Palpate the Child's Testicles Using Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003456', 'term': 'Cryptorchidism'}], 'ancestors': [{'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of correct diagnoses', 'timeFrame': 'Baseline', 'description': 'The primary outcome will be the rate of correct diagnoses made by the medical students compared with the diagnosis made by the consultant surgeon.'}], 'secondaryOutcomes': [{'measure': 'clinical examination score from 0 to 20', 'timeFrame': 'Baseline', 'description': "to assess the student's clinical skills and the quality of the physical examination"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryptorchidism', 'testicular palpation'], 'conditions': ['Testicular Positioning Anomalies', 'Cryptorchidism']}, 'descriptionModule': {'briefSummary': "Hypothesis is that better training of medical students in the examination of boy's external genitalia could improve the diagnosis of testicular position anomalies. To this end, investigators already have created a model to train testicle palpation and recognition of testicular position anomalies. So investigator set up a monocentric randomized controlled trial in wich the medical students will be randomized into 2 groups : a control group receiging only book-based theoretical instruction on the examination of the external genitalia and testicular position anomalies, and a mannequin group receibing, in addition to this conventionnal instruction, simulation training on the mannequin Medical students will then attend a consultation with a child whose reason for coming to the hospital is a testicular positioning anomaly. Students clinical examination will be scored by the consulting senior, and the final diagnosis retained by the student will be compared with that retained by the consulting senior. The aim is to show that medical students who have trained on this new model are better, in terms of clinical examination and diagnostic, than students in the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical student who volunteers to take part in the study during their pediatric or pediatric surgery clerkship or at the simulation center\n\nExclusion Criteria:\n\n* student non in pediatric intership or non in pediatric surgery intership or non at the simulation center intership\n* Student with previous simulation training in the examination of the external genitalia of children'}, 'identificationModule': {'nctId': 'NCT07106502', 'acronym': 'PaTenSim', 'briefTitle': "Learning to Palpate the Child's Testicles Using Simulation", 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Learning to Palpate the Child's Testicles Using Simulation", 'orgStudyIdInfo': {'id': '49RC24_0256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'mannequin simulation-based learning group', 'interventionNames': ['Procedure: testicular palpation training on a mannequin']}], 'interventions': [{'name': 'testicular palpation training on a mannequin', 'type': 'PROCEDURE', 'description': 'Study of testicular palpation training on a mannequin on the ability to perform a testicular examination and diagnose testicular positioning abnormalities', 'armGroupLabels': ['mannequin simulation-based learning group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Louise RENOULT', 'role': 'CONTACT', 'email': 'louise.renoult@chu-angers.fr', 'phone': '2 41 35 42 90', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Louise RENOULT', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}