Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-28 @ 2:03 PM
Study NCT ID:
NCT01597466
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2012-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidrum for Thoracic Epidural Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2012-05-05', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2016-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease to identify the epidural space', 'timeFrame': '30 minutes', 'description': 'Number of cases having required more than 2 punctures and number of failures of the technique'}], 'secondaryOutcomes': [{'measure': 'Duration of epidural procedure', 'timeFrame': '30 minutes'}, {'measure': 'Number of cutaneous punctures', 'timeFrame': '30 minutes'}, {'measure': 'Number of needle redirections', 'timeFrame': '30 minutes'}, {'measure': 'Ease of epidural catheter insertion', 'timeFrame': '30 minutes'}, {'measure': 'Number of inadequate postoperative analgesia', 'timeFrame': 'one day after anesthesia', 'description': 'asymmetric, incomplete or failed analgesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective major thoracic surgery requiring thoracic epidural analgesia\n\nExclusion Criteria:\n\n* Contraindication to epidural anesthesia\n* Marked spinal deformities or a history of spinal instrumentation'}, 'identificationModule': {'nctId': 'NCT01597466', 'acronym': 'Epidrum-Tho', 'briefTitle': 'Epidrum for Thoracic Epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study', 'orgStudyIdInfo': {'id': '2012/01'}, 'secondaryIdInfos': [{'id': '2012-A00083-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidrum', 'description': 'Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)', 'interventionNames': ['Device: Epidural catheter placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loss of resistance technique', 'interventionNames': ['Procedure: Epidural catheter placement']}], 'interventions': [{'name': 'Epidural catheter placement', 'type': 'DEVICE', 'description': 'Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)', 'armGroupLabels': ['Epidrum']}, {'name': 'Epidural catheter placement', 'type': 'PROCEDURE', 'description': 'Epidural space is located using loss of resistance technique (saline solution)', 'armGroupLabels': ['Loss of resistance technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Morgan Le Guen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}, {'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}