Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT02016794
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2013-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Focused Registry on Anterior Cervical Interbody Spacer ACIS
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of neck pain on everyday life measured by the Neck Disability Index (NDI).', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline; 1-2days; 6 weeks; 6 months', 'description': 'Numeric Rating Scale'}, {'measure': 'Handling details', 'timeFrame': 'Intraoperative', 'description': 'easiness of using ACIS, overall satisfaction with ACIS, time of surgery'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Expected average of 5 days', 'description': 'From the day of the surgery until the day of discharge'}, {'measure': 'Adverse Events', 'timeFrame': 'Intra and post operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical', 'interbody', 'spacer', 'degenerative', 'pain', 'neck', 'decompression', 'fusion', 'implant'], 'conditions': ['Degenerative Cervical Spine']}, 'descriptionModule': {'briefSummary': 'Degenerative cervical spine conditions lead to chronic neck and arm pain. Surgical treatment may require anterior decompression and fusion, which usually is established with a cage implant. The Anterior Cervical Interbody Spacer (ACIS) is such a cage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery for degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 years or older\n* Degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels\n* Degenerative cervical disc disease C3 through Th1 or\n* Ruptured and herniated discs C3 through Th1\n* Ability to understand the content of the patient information / informed consent form\n* Willingness and ability to participate in the registry according to the registry plan (RP)\n* Signed and dated IRB / EC-approved written informed consent\n\nExclusion Criteria:\n\n* Spinal tumor\n* Osteoporosis\n* Cervical trauma and instability\n* Any not medically managed severe systemic disease (ie. infection)\n* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment\n* Pregnancy or women planning to conceive within the registry period\n* Prisoner\n* Participation in any other medical device or medicinal product clinical investigation or registry within the previous month that could influence the results of the present registry\n\nIntraoperative exclusion criteria:\n\n* Intraoperative decision to use implants other than the device under investigation'}, 'identificationModule': {'nctId': 'NCT02016794', 'acronym': 'ACIS', 'briefTitle': 'A Focused Registry on Anterior Cervical Interbody Spacer ACIS', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'A Focused Registry on Anterior Cervical Interbody Spacer Procedures in Patients With Cervical Spine Degeneration', 'orgStudyIdInfo': {'id': 'FR_ACIS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients suffering from degenerative cervical condition that requires anterior decompression and fusion in a single or multiple levels'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Brasschaat', 'country': 'Belgium', 'facility': 'AZ Klina', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '2570', 'city': 'Duffel', 'country': 'Belgium', 'facility': 'AZ Sint Maarten', 'geoPoint': {'lat': 51.09554, 'lon': 4.50903}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}