Bone Flap Fixation Systems For Craniotomy Procedures (LOOP2)

NEOS Surgery

Status: Completed

Conditions: Craniotomy

Treatments: Device: Plates and screws; Device: Clamp-like system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04859907

NEO-LOO-2020-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Clamp-like system

Experimental group

Treatment:

Device: Clamp-like system

Plates and screws

Active Comparator group

Treatment:

Device: Plates and screws