Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-03-19
2023-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Clamp-like system
Clamp-like system
Craniotomy closure
Plates and screws
Plates and screws
Craniotomy closure
Interventions
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Clamp-like system
Craniotomy closure
Plates and screws
Craniotomy closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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NEOS Surgery
INDUSTRY
Responsible Party
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Locations
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Maribor University Medical Center
Maribor, , Slovenia
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario la Paz
Madrid, , Spain
Countries
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Other Identifiers
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NEO-LOO-2020-01
Identifier Type: -
Identifier Source: org_study_id
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