Status:
COMPLETED
Bone Flap Fixation Systems For Craniotomy Procedures
Lead Sponsor:
NEOS Surgery
Conditions:
Craniotomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
Eligibility Criteria
Inclusion
- The subject is 18 years or older.
- The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
- At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
- Life expectancy higher than 6 months.
- The subject is willing to give his/her informed consent and to comply with the required follow-up.
Exclusion
- The subject presents any of the contraindications of the assigned craniotomy closure system.
- Orbitozygomatic or mastoid craniotomies.
- Posterior fossa (skull base) surgeries.
- Combined used of craniotomy systems (plates and clamps).
- The subject is currently participating in an investigational drug or device study.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04859907
Start Date
March 19 2021
End Date
February 16 2023
Last Update
August 1 2023
Active Locations (3)
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1
Maribor University Medical Center
Maribor, Slovenia
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
3
Hospital Universitario la Paz
Madrid, Spain, 28046