NCT06010433
Recruiting
Not Applicable
CERAMENT G Device Registry
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- BONESUPPORT AB
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Primary Outcomes
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and over (on the day of surgery)
- •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
- •In receipt of patient information leaflet and have signed appropriately designed informed consent form.
Exclusion Criteria
- •Any exclusion criteria as per IFU for CERAMENT\|G
- •Any off-label use
Outcomes
Primary Outcomes
Primary Outcomes
Time Frame: 12 months
• Device safety - any unexpected device performance, complaints, adverse events, adverse device effects, SAEs throughout study period.
Secondary Outcomes
- Secondary Outcome(12 months)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Withdrawn
Not Applicable
Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) to Treat OsteoarthritisOsteoarthritisNCT02736110Cytori Therapeutics
Unknown
Not Applicable
Registry Evaluation of a Double Balloon Accessory DeviceAdenomatous Polyp of ColonNCT03942965Lumendi, LLC165
Withdrawn
Not Applicable
Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports InjuriesMuscle TearNCT02770755Cytori Therapeutics
Completed
Not Applicable
Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICDMRI ScansMagnetic Resonance ImagingPacemakerImplantable Cardioverter DefibrillatorNCT02318550Lancaster General Hospital262
Unknown
Not Applicable
A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion DeviceCervical Disc DiseaseNCT06240221Research Source200