Bone Flap Fixation Systems For Craniotomy Procedures

Craniotomy Clinical Trial

— LOOP2  

Official title:

Bone Flap Fixation Systems For Craniotomy Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859907
• Other study ID #: NEO-LOO-2020-01
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Craniotomy

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