Recruiting
Early Phase 1

AR Navigation System

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07686211

Conditions

Physician

Surgeon

Resident Doctor

Resident Surgeon

Surgical

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Augmented Reality

Study Details

Brief summary:

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.

Conditions

Physician

Surgeon

Resident Doctor

Resident Surgeon

Surgical

Study ID

NCT07686211

Start date

Feb 18, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Post-graduate year 1, 2, 3, 4 and 5 (PGY2-5) resident physicians. (no age limit)
2. Surgical fellows.
3. Attending physicians.
4. Prior cadaver lab or surgical experience.
5. 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:

1\. Non-physician surgery providers.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jie Ying Wu Assistant Professor of Computer Science, PhD

615-343-4996JieYing.Wu@vanderbilt.edu

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Jie Ying Wu Assistant Professor of Computer Science, PhD

615-343-4996JieYing.Wu@vanderbilt.edu

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 10, 2026

Last verified

Jun, 2026

Keywords

  • physician
  • surgeon
  • resident doctor
  • doctor
  • surgical
  • fellow
  • resident surgeon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-10.