NCT07686211 Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task
| NCT ID | NCT07686211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Physician |
| Study Type | OBSERVATIONAL |
| Enrollment | 51 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 51 participants in total. It began in 2026-02-18 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Michael Topf, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07686211 clinical trial?
This trial is open to participants of all sexes, studying Physician. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07686211 currently recruiting?
Yes, NCT07686211 is actively recruiting participants. Contact the research team at JieYing.Wu@vanderbilt.edu for enrollment information.
Where is the NCT07686211 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07686211 clinical trial?
NCT07686211 is sponsored by Vanderbilt University Medical Center. The principal investigator is Michael Topf, MD at Vanderbilt University Medical Center. The trial plans to enroll 51 participants.