Bone Flap Fixation Systems For Craniotomy Procedures (LOOP2)

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.

Study Overview

• Status: Completed
• Conditions: Craniotomy
• Intervention / Treatment: Device: Clamp-like system; Device: Plates and screws

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Maribor, Slovenia
    • Maribor University Medical Center
• Spain
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clamp-like system	Device: Clamp-like system; Craniotomy closure; Other Names: Cranial LOOP
Active Comparator: Plates and screws	Device: Plates and screws; Craniotomy closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone flap alignment score	1-4	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bone-flap alignment score	1-4	0-7 days after surgery (before discharge)
Surgeon usability questionnaire	Likert scale [1-7], where 1 is very difficult and 7 very easy	0 days after surgery
Device related artefacts in neuroimaging	frequency	6 months
Device-related bulges or visible offsets	frequency	6 months
Post-craniotomy headache	Incidence	6 months

Collaborators and Investigators

• Sponsor: NEOS Surgery

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): November 19, 2022
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NEO-LOO-2020-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No