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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Augmented Reality

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Augmented Reality (AR)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
within 90 minutes of AR-guided use
2

User Experience

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

Time frame
immediately after the AR-guided task.
3

Accuracy of overlay alignment

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Vanderbilt University Medical Center

Lead sponsor

Vanderbilt University

Collaborator