Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 7:55 PM
Study NCT ID:
NCT06010433
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2023-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CERAMENT G Device Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcomes', 'timeFrame': '12 months', 'description': '• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': '12 months', 'description': 'Bone healing at final follow-up'}, {'measure': 'Secondary Outcome', 'timeFrame': '6 and 12 months', 'description': 'Pain and functional assessment at whatever follow-up times are usual for the specific clinical site, for example 6 \\& 12 months, if normally conducted'}, {'measure': 'Secondary Outcome', 'timeFrame': '12 months', 'description': '(Recurrence of) infection/revision surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Osteomyelitis', 'Fracture Related Infection', 'Diabetic Foot Osteomyelitis']}, 'descriptionModule': {'briefSummary': "This is an Observational Device Registry Study of CERAMENT\\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The racial, gender and ethnic characteristics of the individuals approached for participation in this Observational Registry Study shall reflect the demographics of patients that would ordinarily receive CERAMENT\\|G for the treatment of their condition at the designated investigative centres. No individuals shall be excluded from participation in the Observational Registry Study based on race, nationality, ethnicity, gender, or sexuality', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and over (on the day of surgery)\n* receive CERAMENT\\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product\n* In receipt of patient information leaflet and have signed appropriately designed informed consent form.\n\nExclusion Criteria:\n\n* Any exclusion criteria as per IFU for CERAMENT\\|G\n* Any off-label use'}, 'identificationModule': {'nctId': 'NCT06010433', 'briefTitle': 'CERAMENT G Device Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'BONESUPPORT AB'}, 'officialTitle': 'CERAMENT G Device Registry', 'orgStudyIdInfo': {'id': 'S050/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CERAMENT G', 'type': 'DEVICE', 'description': '* Primary mode of action is to be a resorbable ceramic bone graft substitute intended to fill gaps and voids in the skeleton system to promote bone healing. CERAMENT ™\\|G provides a void/gap filler that during the surgical procedure can augment hardware and bone alignments.\n* Secondary mode of action is to prevent colonization of Gentamicin sensitive microorganisms in order to protect bone healing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92104', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Trent Brookshier, DPM', 'role': 'CONTACT', 'email': 'trentbrookshier@gmail.com', 'phone': '6172832097'}, {'name': 'Trent Brookshier, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Park Podiatry', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zach Hutchko, MS', 'role': 'CONTACT', 'email': 'Zachery.Hutchko@orthocarolina.com', 'phone': '704 323 2556'}, {'name': 'Samuel Ford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Nighswander, MPH', 'role': 'CONTACT', 'email': 'alexander.nighswander@uhhospitals.org'}, {'name': 'George Ochenjele, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Brian M Bartholdi', 'role': 'CONTACT', 'email': 'brian.bartholdi@bonesupport.com', 'phone': '16178923927'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BONESUPPORT AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}