Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 8:37 AM
Study NCT ID:
NCT05203666
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-21', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'Baseline', 'description': 'Disability level evaluated with Oswestry Disability Index before intervention'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '3 Months', 'description': 'Disability level evaluated with Oswestry Disability Index after intervention'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale for pain', 'timeFrame': 'Baseline', 'description': 'Pain level from 0 (no pain) to 100 (unbearable pain) before intervention'}, {'measure': 'Visual Analog Scale for pain', 'timeFrame': '3 Months', 'description': 'Pain level from 0 (no pain) to 100 (unbearable pain) after intervention'}, {'measure': 'Variation of foraminal area', 'timeFrame': 'Baseline', 'description': 'Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan'}, {'measure': 'Variation of foraminal area', 'timeFrame': '3 Months', 'description': 'Variation of cross sectional area of neural foramina of the treated level on pre-procedural and post-rocedural CT scan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Lumbar Spinal Stenosis', 'Neurologic Intermittent Claudication']}, 'referencesModule': {'references': [{'pmid': '35641830', 'type': 'DERIVED', 'citation': 'Pavan LJ, Dalili D, De Vivo AE, Hamel-Senecal A, Torre F, Rudel A, Manfre L, Amoretti N. Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience. Neuroradiology. 2022 Sep;64(9):1887-1895. doi: 10.1007/s00234-022-02977-y. Epub 2022 May 31.'}]}, 'descriptionModule': {'briefSummary': 'Purpose To evaluate clinical and radiologic outcome of a series of patients treated with a removable percutaneous interspinous process spacer (IPS) (LobsterProject® Techlamed®) for symptomatic degenerative lumbar spinal stenosis (DLSS).\n\nMethods All patients treated in the two considered Centres with this IPS during 2019 were retrospectively reviewed. Patients with incomplete clinical or radiological documentation were not included. Procedures were performed under deep sedation or general anaesthesia by two interventional radiologists. Patients were clinically evaluated before intervention and at 3-month follow-up with Visual Analog Scale for pain (VAS), Oswestry Disability Index (ODI) and radiologically with MRI or CT scans. Neural foramina were independently measured for each patient on pre- and post-procedural CT scans by two radiologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with this removable percutaneous IPS in our two Centres from December 2018 to February 2020 were retrospectively reviewed and those with complete imaging and clinical data were selected. Patients attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* removable percutaneous IPS treatment\n* attended interventional radiology outpatient consultations for back pain and NIC, refractory to medical treatment\n\nExclusion Criteria:\n\n* PS positioning included cauda equina syndrome\n* permanent motor deficit,\n* previous spine surgery,\n* spondylolisthesis greater than Meyerding grade I,\n* local or systemic infection and severe osteoarthritis with pronounced osteophytosis or bone bridges'}, 'identificationModule': {'nctId': 'NCT05203666', 'acronym': 'LOBSTER', 'briefTitle': 'Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'A Multicentric Retrospective Evaluation of Clinical and Radiologic Outcome of All Patients Treated With a Removable Percutaneous Interspinous Process Spacer (LobsterProject® Techlamed®) for Symptomatic Degenerative Lumbar Spinal Stenosis in 2019.', 'orgStudyIdInfo': {'id': '21Imagerie03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'degenerative lumbar spinal stenosis', 'description': 'All patients treated in 2019 with a percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.', 'interventionNames': ['Other: percutaneous removable interspinous process']}], 'interventions': [{'name': 'percutaneous removable interspinous process', 'type': 'OTHER', 'description': 'percutaneous removable interspinous process spacer a neurologic intermittent clauditation due to a degenerative lumbar spinal stenosis.', 'armGroupLabels': ['degenerative lumbar spinal stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}