Clinical Evidences

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Clinical-Journals

Validation of a dynamic 4D microsurgical bypass simulator for training and teaching microvascular anastomosis techniques with blood flow and fluorescence imaging

Vanluchene HER, Bervini D, Ross Straughan, Samuel Maina, Joseph FJ. “Validation of a dynamic 4D microsurgical bypass simulator for training and teaching microvascular anastomosis techniques with blood flow and fluorescence imaging”. World Neurosurg X. 2024 June

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Even short-term training improves the skills of novice exoscope users: a prospective laboratory experiment @pubMed

Ville Vasankari, Ahmad Hafez, Anni Pohjola, Anna Maria Auricchio, Francesco Calvanese, Tobias Rossmann, Michael Veldeman,Ines Badic, Eliisa Netti, Ilari Rautalin, Ville Nurminen, Rahul Raj, Mika Niemelä, and Martin Lehecka. Even short-term training improves the skills of novice exoscope users: a prospective laboratory experiment. 2024 Mar 1. doi: 10.1007/s00701-024-05975-6; PMID: 38427127; PMCID: PMC10907429

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Training Performance Assessment for Intracranial Aneurysm Clipping Surgery Using a Patient-Specific Mixed-Reality Simulator: A Learning Curve Study @CNS Operative Surgery

Cuba, Miguel BSc; Vanluchene, Hanne MSc; Murek, Michael MD; Goldberg, Johannes MD; Müller, Mandy D. MD, PhD; Montalbetti, Matteo MD; Janosovits, Katharina MD; Rhomberg, Thomas MD; Zhang, David MD; Raabe, Andreas MD; Joseph, Fredrick J. PhD; Bervini, David MD, MAvdSurg. Training Performance Assessment for Intracranial Aneurysm Clipping Surgery Using a Patient-Specific Mixed-Reality Simulator: A Learning Curve Study. Operative Surgery ():10.1227/ons.0000000000001041, January 22, 2024. | DOI: 10.1227/ons.0000000000001041

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Dynamic Mixed-Reality Patient-Specific Aneurysm Clipping Simulation for Two Cases-A Feasibility Study @pubMed

Joseph FJ, Cuba M, Murek M, Raabe A, Bervini D. Dynamic Mixed-Reality Patient-Specific Aneurysm Clipping Simulation for Two Cases-A Feasibility Study. Oper Neurosurg (Hagerstown). 2023 Dec 6. doi: 10.1227/ons.0000000000001017. Epub ahead of print. PMID: 38054703.

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Simulation training approaches in intracranial aneurysm surgery-a systematic review @pubMed

Joseph FJ, Vanluchene HER, Bervini D. Simulation training approaches in intracranial aneurysm surgery-a systematic review. Neurosurg Rev. 2023 May 3;46(1):101. doi: 10.1007/s10143-023-01995-5. PMID: 37131015; PMCID: PMC10154262.

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Neurosurgical simulator for training aneurysm microsurgery-a user suitability study involving neurosurgeons and residents @springerlink

Joseph FJ, Weber S, Raabe A, Bervini D. Neurosurgical simulator for training aneurysm microsurgery-a user suitability study involving neurosurgeons and residents.Acta Neurochir (Wien). 2020 Oct;162(10):2313-2321. doi: 10.1007/s00701-020-04522-3. Epub 2020 Aug 11. PMID: 32780255; PMCID: PMC7496061.

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3D-Printed Head Model in Patient’s Education for Micro-Neurosurgical Aneurysm Clipping Procedures. @pubmed

Joseph FJ, Vanluchene HER, Goldberg J, Bervini D. 3D-Printed Head Model in Patient’s Education for Micro-Neurosurgical Aneurysm Clipping Procedures. World Neurosurg. 2023 Apr 21:S1878-8750(23)00555-7. doi: 10.1016/j.wneu.2023.04.070. Epub ahead of print. PMID: 37087042.

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Frequently asked questions

These are the most commonly asked questions. can't find what you are looking for use our chatbot.

  • What is clinical evidence in surgical simulation?

    Clinical evidence in surgical simulation refers to systematically collected data demonstrating how simulation-based surgical training improves performance and outcomes...
  • What does "clinically evident" mean?

    Clinically evident refers to symptoms, responses, or outcomes that are observable and measurable during a medical evaluation...
  • What is acceptable clinical evidence?

    Acceptable clinical evidence is data generated through well-structured medical clinical studies or simulations that meet predefined quality and safety standards...
  • What is the impact factor of the clinical review journal?

    The impact factor of a clinical review journal indicates how frequently its articles are cited and reflects the influence of its published research...
  • What is the validation of medical devices?

    Validation of medical devices is the process of ensuring that a device performs safely and effectively in clinical scenarios...
  • What is clinical validation of medical devices from a general perspective?

    Clinical validation, from a general perspective, involves testing medical devices in real-world clinical or simulated settings to confirm their effectiveness and safety...
  • What is the difference between clinical validation and verification?

    Verification checks whether a device meets design specifications, while clinical validation ensures it performs safely and effectively in real-world conditions...
  • What type of tools do neurosurgeons use?

    Neurosurgeons rely on specialized tools, including microscissors, forceps, suturing needles, spinal instruments, and clips...
  • What can evidence-based practice questions ask?

    Evidence-based practice questions typically ask about the effectiveness, safety, or applicability of a medical intervention...
  • What is the microvascular anastomosis technique?

    Microvascular anastomosis is a surgical method that connects small blood vessels using fine suturing needles...
  • How is microvascular surgery performed?

    Microvascular surgery involves the use of specialized microsurgical instruments to join tiny blood vessels under magnification...
  • What do clinical studies do?

    Clinical studies provide essential clinical evidence by systematically testing medical interventions and devices...
  • What is an example of a clinical study?

    A typical clinical evidence example is a study evaluating microvascular anastomosis techniques to validate surgical training...
  • What is an evidence journal?

    An evidence journal publishes peer-reviewed research offering clinical evidence that informs best practices in medicine...
  • What is a clinical assessment process?

    The clinical assessment process evaluates a patient's health through observations, tests, and comprehensive history-taking...
  • What are the 4 levels of evidence?

    The four levels of evidence classify clinical studies by quality, from randomized controlled trials (highest) to expert opinions (lowest)...
  • What is the medical evidence?

    Medical evidence comprises data from clinical studies, trials, and assessments used to support diagnosis, treatment, and the validation of medical devices...
  • Do clinical studies pay well?

    Clinical studies focusing on simulation-based surgical training and medical device validation often receive institutional or grant funding...
  • What clinical trials pay the most?

    Trials involving complex procedures, such as intracranial aneurysm clipping or dynamic mixed-reality simulations, may have higher budgets...
  • What is the cost of obtaining clinical evidence for medical devices?

    Costs vary by device complexity, ranging from $6,000 to $19,000 per subject for trials validating simulation platforms or 3D-printed models...
  • How is the amount of clinical evidence determined?

    Regulatory requirements, risk classification, and intended use determine the scope of evidence...
  • What are the costs associated with obtaining clinical evidence?

    Key expenses include simulation software licensing ($10,000–$50,000), 3D-printed anatomical models ($2,000–$15,000 per unit), and personnel training...
  • What are the costs associated with regulatory submissions and approvals?

    Submissions for devices like endovascular simulators incur fees for FDA/EU MDR reviews ($20,000–$500,000)...


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