Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04682418
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2019-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pedicle Screw Placement With XVS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-22', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accurate placement of pedicle screws', 'timeFrame': 'through study completion , an average of 6 months.', 'description': 'accurate placement will be evaluated using Gertzbein and Robbins'}], 'secondaryOutcomes': [{'measure': 'usability and ease of use of the system: questionnaire', 'timeFrame': 'The surgeon fills a questionnaire after the surgery, within 7 days.', 'description': 'usability will be evaluated by questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spine Fusion']}, 'descriptionModule': {'briefSummary': 'Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.\n\nPedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score.\n\nSubjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration.\n\nSubjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score.\n\nSurgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects aged 18 - 80 yrs.\n2. Subjects with Spondylosis scheduled to undergo an elective short (6 or less consecutive vertebrae) S1-L1 open spinal fixation surgery using pedicle screws.\n3. Subjects requiring a posterior approach surgical procedure.\n4. Subjects with normal global spinal alignment (coronal, sagittal view) and/ or patients with degenerative spine disorders.\n\nExclusion Criteria:\n\n1. Subjects with severe Osteoporosis (T score \\<-3.5)\n2. Subjects with kyphosis at the operated area (≥ stage 3)\n3. Subjects with Spondylolisthesis Grade III and above.\n4. Subjects scheduled for revision fusion surgery (prior laminectomy or discectomy is not excluded).\n5. Subjects with significant abnormalities of bones (e.g. osteogenesis imperfecta, tumors, infection or malignancy, etc.)\n6. Subjects with neurologic diseases or damage (e.g. due to trauma, tumor, Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)\n7. Subjects with spinal cord abnormalities with any neurologic symptoms or signs\n8. Paraplegia.\n9. Pedicle fracture documented before or during surgery.\n10. Women pregnant or lactating\n11. Subjects requiring anterior release or instrumentation.\n12. Subjects who are unwilling to sign written informed consent and assent to participate in the study.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT04682418', 'briefTitle': 'Pedicle Screw Placement With XVS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Augmedics'}, 'officialTitle': 'Feasibility Study of Pedicle Screw Placement in the Spine With the XVISION SPINE System', 'orgStudyIdInfo': {'id': 'DHF-VAP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'xvision Spine', 'interventionNames': ['Device: xvision Spine sytem']}], 'interventions': [{'name': 'xvision Spine sytem', 'type': 'DEVICE', 'otherNames': ['XVS'], 'description': 'pedicle screw placement will be performed using the XVS navigation system', 'armGroupLabels': ['xvision Spine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek MC', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheeba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '70300', 'city': 'Tzrifin', 'country': 'Israel', 'facility': 'Asaf Harofeh', 'geoPoint': {'lat': 31.95649, 'lon': 34.84002}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augmedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}