Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 4:46 AM
Study NCT ID:
NCT07017634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': '24 months after surgery', 'description': 'Meet all of the following conditions:\n\n1. Fusion success\n2. Oswestry Disability Index success\n3. Neurological success\n4. No subsequent surgical interventions\n5. No related serious event'}], 'secondaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': '6 and 12 months after surgery', 'description': 'Meet all of the following conditions:\n\n1. Fusion success\n2. Oswestry Disability Index success\n3. Neurological success\n4. No subsequent surgical interventions\n5. No related serious event'}, {'measure': 'ODI score', 'timeFrame': '6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery', 'description': 'Evaluate Oswestry Disability Index(ODI) score/ lowest 0(best) to highest 100(worst)'}, {'measure': 'VAS score', 'timeFrame': '6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery', 'description': 'Evaluate Visual Analog Scale(VAS) score/ none (0 mm) to an extreme amount of pain (100mm)'}, {'measure': 'SF-12 score', 'timeFrame': '6weeks, 3, 6, 12, 24, 36, 48 and 60months after surgery', 'description': 'Evaluate SF-12 scores / lowest 0(worst) to highest 100(best)'}, {'measure': 'Intraoperative variables', 'timeFrame': 'Intraoperative', 'description': 'Surgery time, blood loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Degenerative Disc Disease']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar confirmed by subject history and radiographic imaging (CT, MRI, X-rays) with no more than a Grade 2 (≤50% translation) spondylolisthesis. Symptomatic lumbar degeneration (L1 to S1) that may be associated with a co-morbid condition.\n* Has preoperative Oswestry Disability Index score ≥ 40/100 at baseline\n* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;\n* Degenerative or lytic spondylolisthesis greater than Grade 2 (50% translation);\n* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;\n* Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;\n* Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;\n* Lactating, pregnant or interested in becoming pregnant in the next 3 years;\n* Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.\n* Known hypersensitivity or allergy to any components of the study treatments inclusive of hypersensitivity or allergy to any BMP-2 type recombinant proteins or peptides."}, 'identificationModule': {'nctId': 'NCT07017634', 'briefTitle': 'Efficacy and Safety of NOVOSIS Putty for Interbody Lumbar Fusion Cases', 'organization': {'class': 'INDUSTRY', 'fullName': 'CGBio Inc.'}, 'officialTitle': 'Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study', 'orgStudyIdInfo': {'id': 'CGNVP002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Novosis Putty', 'interventionNames': ['Device: Novosis Putty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Novosis Putty', 'type': 'DEVICE', 'description': 'Single Level TLIF surgery with Novosis Putty', 'armGroupLabels': ['Novosis Putty']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Single Level TLIF surgery with standard of care bone graft', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jumi Han', 'role': 'CONTACT', 'email': 'Jumi.Han@CGBioUSA.com', 'phone': '1.949.445.5965'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CGBio Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CGBio USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}