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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07686211
Status
Recruiting

Conditions

  • Fellow
  • Physician
  • Resident Doctor
  • Resident Surgeon
  • Surgeon
  • Surgical

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
51 participants (estimated)

Arms

  • Arm: Augmented Reality (AR)
    Participants will be asked to localize simulated margins on tissue resection beds on a fresh-frozen cadaver head. Specimens of skin, buccal, or tongue tissue will be resected by the research team beforehand. Participants will be asked to place pins or stitches where the indicated targets are located. These positions will be recorded by the research team. Participants will first receive oral guidance only, corresponding to common descriptions between pathologists and surgeons. Participants will then reproduce the same task with AR guidance. In this case, the target will be displayed in the see-through AR headset. The target will be overlaid on the resection bed site and follow your head's movements.

Primary Outcome Measure

Performance Task accuracy (e.g., resection precision) [ Time Frame: within 90 minutes of AR-guided use ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Jie Ying Wu Assistant Professor of Computer Science, PhD
615-343-4996

Find similar trials in Nashville, TN

Related Studies