Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 4:45 PM
Study NCT ID:
NCT00939406
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2009-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
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': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2009-07-14', 'studyFirstSubmitQcDate': '2009-07-14', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of adverse events', 'timeFrame': '6 months'}, {'measure': 'Extent of epidural fibrosis', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Spinal Stenosis', 'Disk Herniation']}, 'descriptionModule': {'briefSummary': 'The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.\n* Subjects who have failed conservative care for at least 6 weeks.\n\nExclusion Criteria:\n\n* Contraindication to MRI\n* Instrumented fusion'}, 'identificationModule': {'nctId': 'NCT00939406', 'acronym': 'Hyalospine', 'briefTitle': 'Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy', 'orgStudyIdInfo': {'id': 'Hyalospine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone'}, {'type': 'EXPERIMENTAL', 'label': 'Hyalospine', 'description': 'Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.', 'interventionNames': ['Device: Hyalospine']}], 'interventions': [{'name': 'Hyalospine', 'type': 'DEVICE', 'description': 'Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.', 'armGroupLabels': ['Hyalospine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Woerden', 'country': 'Netherlands', 'facility': 'Sint Maartenskliniek, Nijmegen, The Netherlands', 'geoPoint': {'lat': 52.085, 'lon': 4.88333}}, {'zip': '3006', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Klinik Sonnehof', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Paul Pavlov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint Maartenskliniek, Nijmegen, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}