Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-25 @ 4:57 PM
Study NCT ID:
NCT05631392
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index (NDI) Questionnaire', 'timeFrame': '24 months', 'description': 'Set of questions given to the subjects about experiencing pain during activities that are marked on a scale of 0-5 - whereby "0" is no pain and "5" is the worse pain. Maximum score for the questionnaire of "50" is possible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Disc Degeneration']}, 'descriptionModule': {'briefSummary': 'Observational data collection of information after undergoing standard Cervical spine fusion surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective study so patient population taken from those undergoing cervical spine fusion surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.\n2. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery).\n3. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated.\n4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).\n5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.\n\nExclusion Criteria:\n\n1. Subjects who have undergone previous spinal surgery either anterior or posterior.\n2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.\n3. Subjects with a known allergy to the material used in the instrumentation.\n4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.\n5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.\n6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.'}, 'identificationModule': {'nctId': 'NCT05631392', 'briefTitle': 'Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invibio Ltd'}, 'officialTitle': 'A Prospective, Non-randomised, Multi-centre, Post-market Clinical Follow-up Observational Study to Evaluate the Clinical and Radiographic Outcomes of the BEE® HA Cage for Anterior Cervical Discectomy and Fusion.', 'orgStudyIdInfo': {'id': 'NGM01'}}, 'contactsLocationsModule': {'locations': [{'zip': '06112', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Yvonne Minkus', 'role': 'CONTACT'}], 'facility': 'Bg Klinikum Bergmannstrost Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'centralContacts': [{'name': 'Karen 2 Robson', 'role': 'CONTACT', 'email': 'karen.robson@invibio.com', 'phone': '07765220492'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invibio Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NGMedical GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}