Evidence-based cross validation for acoustic power transmission for a novel treatment system

Senay Mihcin (Lead / Corresponding author), Jan Strehlow, Daniel Demedts, Michael Schwenke, Yoav Levy, Andreas Melzer

    Research output: Contribution to journalArticle

    3 Citations (Scopus)
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    Abstract

    INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.

    MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.

    RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).

    CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.

    Original languageEnglish
    Pages (from-to)151-161
    Number of pages14
    JournalMinimally Invasive Therapy and Allied Technologies
    Volume26
    Issue number3
    Early online date13 Jan 2017
    DOIs
    Publication statusPublished - 2017

    Keywords

    • Acoustic power measurement for reliability,
    • Bland-Altman
    • Cross-validation
    • Quality assurance
    • Legislation
    • Pre-clinical MRgFUS
    • Two-sample t-test

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