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NCT07686211 · ClinicalTrials.gov registry record
Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- 51
- Enrollment target
NCT07686211: Recruiting study, sponsored by Vanderbilt University Medical Center.
NCT07686211 is a clinical trial that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07686211 is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
Surgeon performance of target re-localization compared with and without the AR-headset.
Interventions
- OTHER Augmented Reality
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2026-02-18 |
| Est. Completion | 2029-06 |
What NCT07686211 shows while recruiting
NCT07686211 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Augmented Reality is the first listed.
NCT07686211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07686211 about?
NCT07686211 is a clinical study titled "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. Curren...
What is the current status of trial NCT07686211?
This trial is currently recruiting. The enrollment target is 51 participants. The study started on 2026-02-18. Estimated completion is 2029-06.
What interventions are being tested in trial NCT07686211?
The interventions under investigation include: Augmented Reality (OTHER).
Who is sponsoring clinical trial NCT07686211?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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