Bone Flap Fixation Systems For Craniotomy Procedures

NCT ID: NCT04859907

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2023-02-16

Brief Summary

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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.

Detailed Description

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Conditions

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Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clamp-like system

Group Type EXPERIMENTAL

Clamp-like system

Intervention Type DEVICE

Craniotomy closure

Plates and screws

Group Type ACTIVE_COMPARATOR

Plates and screws

Intervention Type DEVICE

Craniotomy closure

Interventions

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Clamp-like system

Craniotomy closure

Intervention Type DEVICE

Plates and screws

Craniotomy closure

Intervention Type DEVICE

Other Intervention Names

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Cranial LOOP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NEOS Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maribor University Medical Center

Maribor, , Slovenia

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario la Paz

Madrid, , Spain

Site Status

Countries

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Slovenia Spain

Other Identifiers

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NEO-LOO-2020-01

Identifier Type: -

Identifier Source: org_study_id

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