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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04859907
Other study ID # NEO-LOO-2020-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2021
Est. completion date February 16, 2023

Study information

Verified date February 2023
Source NEOS Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Clamp-like system
Craniotomy closure
Plates and screws
Craniotomy closure

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
NEOS Surgery

Countries where clinical trial is conducted

Slovenia,  Spain, 

Outcome

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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