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Completed

NCT Number: NCT04859907

Bone Flap Fixation Systems For Craniotomy Procedures

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.

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Key information

Conditions

Craniotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maribor University Medical Center, Maribor, Slovenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clamp-like system

Device

Craniotomy closure

Other names: Cranial LOOP

Plates and screws

Device

Craniotomy closure

Primary outcomes

  1. Bone flap alignment score

    Time frame: 6 months

    1-4

Secondary outcomes

  1. Frequency of adverse effects and device deficiencies (device safety)

    Time frame: 6 months

    Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies

  2. Bone-flap alignment score

    Time frame: 0-7 days after surgery (before discharge)

    1-4

  3. Surgeon usability questionnaire

    Time frame: 0 days after surgery

    Likert scale [1-7], where 1 is very difficult and 7 very easy

  4. Device related artefacts in neuroimaging

    Time frame: 6 months

    frequency

  5. Device-related bulges or visible offsets

    Time frame: 6 months

    frequency

  6. Post-craniotomy headache

    Time frame: 6 months

    Incidence

Sponsors and collaborators

Lead sponsor

NEOS Surgery

Industry

Registry information

Acronym: LOOP2

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 26, 2021
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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