Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task

Обзор

Head and neck cancers have one of the highest recurrence rates among solid malignancies, and recurrence is strongly correlated with overall survival. Reducing recurrence rates depends, in part, on the surgeon's ability to accurately re-resect areas of positive or close margins during surgery. Currently, margin status is communicated primarily through verbal descriptions between the surgeon and pathologist, which can be imprecise. This challenge is further compounded by the deformable nature of soft tissues, as once the specimen is resected, the shape and size of the specimen change, making it difficult to accurately map the specimen's margins back onto the surgical site. Emerging technologies -such as augmented reality (AR), 3D scanning, and advanced soft tissue modeling- offer promising solutions for improving surgical navigation and precision. Building on these advances, an AR-based surgical navigation system was developed specifically for head and neck tumor resections. The system uses a 3D scanner to generate virtual models of both the resected specimen and the patient's surgical site, as demonstrated in prior work. A soft tissue modeling algorithm is then applied to account for specimen shrinkage and deformation, enabling accurate tracking of positive tumor margins. This guidance information is visualized through an AR headset, which overlays the margin data directly onto the patient's surgical site, providing surgeons with real-time visual guidance during re-resection. In this study, the goal is to evaluate the benefits and usability of this novel navigation software, compared to the standard of care. By assessing surgeon performance and user experience in cadaveric tasks with and without the AR system to identify strengths, limitations, and opportunities for refinement of the system, ultimately advancing surgical precision and improving patient outcomes by reducing recurrence rates.

Подробное описание

Augmented reality (AR) technology, combined with computer vision algorithms, offers significant potential to enhance surgical visualization by generating GPS-like spatial maps over the patient's anatomy. This study aims to evaluate the usability and impact of our AR surgical guidance system, delivered through Microsoft HoloLens 2 (or equivalent AR/VR goggles such as Magic Leap or Apple Vision Pro), among surgeons while they complete various surgical tasks on cadaveric specimens. Specifically, an assessment of how the AR system influences surgeon performance and user experience during tasks such as suturing and specimen relocation, performed both with and without AR assistance.

Task accuracy (e.g., resection precision) will be measured and survey responses will be collected to assess the system's usability, ease of use, and comfort. Building on prior work where the investigators validated the feasibility and accuracy of AR-guided surgical holograms, this study focuses on advancing the evaluation of the system's usability and impact on performance. The goal is to generate insights into the application of AR guidance in head and neck tumor resection, ultimately contributing to improved intraoperative surgical precision and patient outcomes.

Вмешательства

• Другое Augmented Reality
  Task accuracy will be evaluated by measuring distances between the points identified with and without AR guidance, and the pathologist-intended target locations. Participants will then complete post-tasks surveys and interviews.

Первичные конечные точки

• Performance Task accuracy (e.g., resection precision) [Срок оценки: within 90 minutes of AR-guided use]
• User Experience [Срок оценки: immediately after the AR-guided task.]
• Accuracy of overlay alignment [Срок оценки: within 90 minutes of completing the AR-guided task.]

Критерии участия

Критерии включения

• Post-graduate year 1, 2, 3, 4 and 5 (PGY2-5) resident physicians. (no age limit)
• Surgical fellows.
• Attending physicians.
• Prior cadaver lab or surgical experience.
• Any surgeon, regardless of training and experience, who has been involved in the surgeon-pathologist interaction during surgical resection for frozen section and margin clearance assessment.

Критерии исключения

1\. Non-physician surgery providers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07686211 · 251090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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