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NCT Number: NCT07686211

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Jie Ying Wu Assistant Professor of Computer Science, PhD

CONTACT

[email protected]

615-343-4996

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Non-physician surgery providers.

Treatment and study plan

Augmented Reality

Other

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.

Primary outcomes

  1. Performance Task accuracy (e.g., resection precision)

    Time frame: within 90 minutes of AR-guided use

    Surgeon performance of target re-localization compared with and without the AR-headset.

  2. User Experience

    Time frame: immediately after the AR-guided task.

    Assess AR usability, ease of use, and comfort, through surgeon feedback surveys

  3. Accuracy of overlay alignment

    Time frame: within 90 minutes of completing the AR-guided task.

    This will validate the accuracy of overlay alignment through landmark-based (tumor margin relocation) error metrics, which support precision of re-resection tasks.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Ying Wu Assistant Professor of Computer Science, PhD

CONTACT

[email protected]

615-343-4996

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Vanderbilt University

Registry information

Acronym: SPeAR

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 7, 2026
Registry last updated
Jul 8, 2026

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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