Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-28 @ 12:56 AM
Study NCT ID:
NCT03916666
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Low Back Pain - Epiduroscopy Treatment
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': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of back pain after epiduroscopic procedure', 'timeFrame': '1 year'}, {'measure': 'Incidence of leg pain after epiduroscopic procedure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Retrospective analysis of patients with low back pain after epiduroscopic procedure', 'detailedDescription': 'Retrospective analysis of patients with low back pain after epiduroscopic procedure Retrospective analysis of ambulatory data and next phone survey'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'After epiduroscopy, FBSS Y/N', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients after epiduroscopy\n\nExclusion Criteria:\n\n* patients disagreement'}, 'identificationModule': {'nctId': 'NCT03916666', 'briefTitle': 'Chronic Low Back Pain - Epiduroscopy Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Pavol Jozef Safarik University'}, 'officialTitle': 'Chronic Low Back Pain - Epiduroscopy Treatment', 'orgStudyIdInfo': {'id': 'EPCSVII'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epiduroscopy', 'type': 'PROCEDURE', 'description': 'Endoscopic intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110 00', 'city': 'Prague', 'state': 'Smetanovo Nábřeží 327/14', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Ladislav Kočan, MD PhD', 'role': 'CONTACT', 'email': 'europainclinicsstudy@gmail.com'}, {'name': 'Róbert Rapčan, MD', 'role': 'CONTACT'}, {'name': 'Miroslav Buriánek, MD MBA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'EuroPainClinics .z.ú', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '04011', 'city': 'Košice', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Ladislav Kocan, MD PhD', 'role': 'CONTACT'}], 'facility': 'East Slovak Institute for Cardiovascular Diseases', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}], 'centralContacts': [{'name': 'Ladislav Kocan, MD PhD', 'role': 'CONTACT', 'email': 'lkocan@vusch.sk', 'phone': '00421907440250'}, {'name': 'Robert Rapcan, MD PhD', 'role': 'CONTACT', 'email': 'rapcan@europainclinics.sk', 'phone': '00421907440250'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pavol Jozef Safarik University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Europainclinics z.ú.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kočan Ladislav', 'investigatorAffiliation': 'Pavol Jozef Safarik University'}}}}