Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-29 @ 2:56 PM
Study NCT ID:
NCT06827795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability and performance of the medical device Surgify Halo ™ in revision spine surgery', 'timeFrame': 'From enrollment to the end of the surgery until the end of the stay in the recovery room.', 'description': 'Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spine Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to:\n\ntest the usability and performance of the medical device Surgify Halo ™ in revision spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).\n\nThis medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.\n\nThe target is to enroll 30 participants in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Disease of the spine or head requiring surgery with bone removal\n\n * Ability to understand the purpose and risks of the study and to give written informed consent\n * Age 21-85 years\n\nExclusion Criteria:\n\n* Previous surgery in the same area\n\n * Abnormalities of bone tissue\n * Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women\n * Allergy or hypersensitivity to medical-grade stainless steel or any alloying components\n * Problems with blood clotting'}, 'identificationModule': {'nctId': 'NCT06827795', 'briefTitle': 'An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Surgify Medical Oy'}, 'officialTitle': 'An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)', 'orgStudyIdInfo': {'id': 'Pro00079896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surgify Halo', 'interventionNames': ['Device: A burr used in spine surgery']}, {'type': 'OTHER', 'label': 'State of art Rosen burr', 'interventionNames': ['Device: A burr used in spine surgery']}], 'interventions': [{'name': 'A burr used in spine surgery', 'type': 'DEVICE', 'description': 'A burr used in spine surgery', 'armGroupLabels': ['State of art Rosen burr', 'Surgify Halo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Surgify Medical Oy', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'North Shore University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}