Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05277818
Status:
RECRUITING
Last Update Posted:
2022-10-31
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-marketing Clinical Follow-up of the Medical Device DIVA®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 822}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of patients requiring reoperation for any cause (excluding trauma) on the lumbar spine 5 years postoperatively.', 'timeFrame': '5 years', 'description': 'The main analysis will compare the rates of patients requiring reoperation due to any cause (excluding trauma) on the lumbar spine 5 years after surgery between the group with DIVA® and the group without DIVA®, using a Chi-square test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'Observational, ambispective, longitudinal, comparative, open, multicentric study.\n\nThe main objective is to compare the performance of care in patients operated with and without DIVA®.', 'detailedDescription': 'The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "All patients with the DIVA® device operated in the study centers for at least 12 months (with the exception of the first 30 operated by practitioner, to take into account the learning curve), as well as all patients operated on over a period similar before the installation of DIVA® in the establishment, will receive the information note of the study. if the patient agrees to participate to the study, patient's data will be collected on a case report form.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;\n* Patient operated for at least 12 months;\n* Patient able to understand the information related to the study;\n* Patient having indicated his/her non-opposition to the collection of his/her personal data.\n\nExclusion Criteria:\n\n* History of pathologies, malformations or surgical interventions on the spine;\n* Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;\n* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);\n* Patient not benefiting from a social security scheme.'}, 'identificationModule': {'nctId': 'NCT05277818', 'briefTitle': 'Post-marketing Clinical Follow-up of the Medical Device DIVA®', 'organization': {'class': 'INDUSTRY', 'fullName': 'SC Medica'}, 'officialTitle': 'Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery', 'orgStudyIdInfo': {'id': '2021-A02667-34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with medical device DIVA®', 'description': 'Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant', 'interventionNames': ['Procedure: Surgery lumbar disc herniation']}, {'label': 'Patient without medical device DIVA®', 'description': 'Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant', 'interventionNames': ['Procedure: Surgery lumbar disc herniation']}], 'interventions': [{'name': 'Surgery lumbar disc herniation', 'type': 'PROCEDURE', 'description': 'Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation', 'armGroupLabels': ['Patient with medical device DIVA®', 'Patient without medical device DIVA®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colmar', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Robin SROUR, MD', 'role': 'CONTACT', 'email': 'robin.srour@ch-colmar.fr'}], 'facility': 'Hôpitaux Civils de Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}], 'centralContacts': [{'name': 'Aurélie MULLER', 'role': 'CONTACT', 'email': 'dpo@sc-medica.com', 'phone': '+33 3 88 23 71 04'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SC Medica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}