Craniotomy Clinical Trial
— LOOP2Official title:
Bone Flap Fixation Systems For Craniotomy Procedures
Verified date | February 2023 |
Source | NEOS Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 16, 2023 |
Est. primary completion date | November 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Slovenia | Maribor University Medical Center | Maribor | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Universitario la Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
NEOS Surgery |
Slovenia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone flap alignment score | 1-4 | 6 months | |
Secondary | Frequency of adverse effects and device deficiencies (device safety) | Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies | 6 months | |
Secondary | Bone-flap alignment score | 1-4 | 0-7 days after surgery (before discharge) | |
Secondary | Surgeon usability questionnaire | Likert scale [1-7], where 1 is very difficult and 7 very easy | 0 days after surgery | |
Secondary | Device related artefacts in neuroimaging | frequency | 6 months | |
Secondary | Device-related bulges or visible offsets | frequency | 6 months | |
Secondary | Post-craniotomy headache | Incidence | 6 months |
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