PhysicianEarly Phase 1SPeARNCT07686211
Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task
A Early Phase 1 study testing Augmented Reality in people with Physician and Surgeon, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physician, Surgeon, Resident Doctor
- What is being tested?
- Augmented Reality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Jun 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 1. Non-physician surgery providers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jie Ying Wu Assistant Professor of Computer Science, PhD contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jie Ying Wu Assistant Professor of Computer Science, PhD, 615-343-4996, JieYing.Wu@vanderbilt.edu
About this study
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.
Read the detailed description
Augmented reality (AR) technology, combined with computer vision algorithms, offers significant potential to enhance surgical visualization by generating GPS-like spatial maps over the patient's anatomy. This study aims to evaluate the usability and impact of our AR surgical guidance system, delivered through Microsoft HoloLens 2 (or equivalent AR/VR goggles such as Magic Leap or Apple Vision Pro), among surgeons while they complete various surgical tasks on cadaveric specimens. Specifically, an assessment of how the AR system influences surgeon performance and user experience during tasks such as suturing and specimen relocation, performed both with and without AR assistance.
Task accuracy (e.g., resection precision) will be measured and survey responses will be collected to assess the system's usability, ease of use, and comfort. Building on prior work where the investigators validated the feasibility and accuracy of AR-guided surgical holograms, this study focuses on advancing the evaluation of the system's usability and impact on performance. The goal is to generate insights into the application of AR guidance in head and neck tumor resection, ultimately contributing to improved intraoperative surgical precision and patient outcomes.
- Conditions
- Physician, Surgeon, Resident Doctor, Resident Surgeon, Surgical, Fellow
- Being tested
- Augmented Reality
- Keywords
- physician, surgeon, resident doctor, doctor, surgical, fellow, resident surgeon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityOther
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 group | Role | What they receive |
|---|---|---|
| Augmented Reality (AR) | Other | 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. Receives: Other: Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Task accuracy (e.g., resection precision)
Surgeon performance of target re-localization compared with and without the AR-headset.
Measured: within 90 minutes of AR-guided use
User Experience
Assess AR usability, ease of use, and comfort, through surgeon feedback surveys
Measured: immediately after the AR-guided task.
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.
Measured: within 90 minutes of completing the AR-guided task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start18 Feb 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysicianStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Michael Topf, Vanderbilt University Medical Center
- Investigators
- Michael Topf, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686211
- Sponsor's protocol ID
- 251090
- Acronym
- SPeAR
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NIH requires through Data Management and Sharing Plans (DMSP) that all data collected during the research project be archived indefinitely and shared with the community after the project termination. De-identified data will then be transferred to Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task
- ClinicalTrials.gov ID
- NCT07686211
- Acronym / sponsor ID
- SPeAR / 251090
- Conditions
- Physician, Surgeon, Resident Doctor, Resident Surgeon, Surgical, Fellow
- Keywords
- physician, surgeon, resident doctor, doctor, surgical, fellow, resident surgeon
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Augmented reality (AR) technology, combined with computer vision algorithms, offers significant potential to enhance surgical visualization by generating GPS-like spatial maps over the patient's anatomy. This study aims to evaluate the usability and impact of our AR surgical guidance system, delivered through Microsoft HoloLens 2 (or equivalent AR/VR goggles such as Magic Leap or Apple Vision Pro), among surgeons while they complete various surgical tasks on cadaveric specimens. Specifically, an assessment of how the AR system influences surgeon performance and user experience during tasks such as suturing and specimen relocation, performed both with and without AR assistance.
Task accuracy (e.g., resection precision) will be measured and survey responses will be collected to assess the system's usability, ease of use, and comfort. Building on prior work where the investigators validated the feasibility and accuracy of AR-guided surgical holograms, this study focuses on advancing the evaluation of the system's usability and impact on performance. The goal is to generate insights into the application of AR guidance in head and neck tumor resection, ultimately contributing to improved intraoperative surgical precision and patient outcomes.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality (AR) | Other | Other: Augmented RealityParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 1. Non-physician surgery providers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented RealityTask 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. | Other | Augmented Reality (AR) |
Primary outcome
Performance Task accuracy (e.g., resection precision)
Time frame: within 90 minutes of AR-guided use
Surgeon performance of target re-localization compared with and without the AR-headset.
User Experience
Time frame: immediately after the AR-guided task.
Assess AR usability, ease of use, and comfort, through surgeon feedback surveys
Accuracy of overlay alignment
Time frame: within 90 minutes of completing the AR-guided task.
This will validate the accuracy of overlay alignment through landmark-based (tumor margin relocation) error metrics, which support precision of re-resection tasks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided. NIH requires through Data Management and Sharing Plans (DMSP) that all data collected during the research project be archived indefinitely and shared with the community after the project termination. De-identified data will then be transferred to Open Science Framework (OSF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jie Ying Wu Assistant Professor of Computer Science, PhD contact
Michael Topf, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Augmented Reality in people with Physician and Surgeon, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Ying Wu Assistant Professor of Computer Science, PhD (615-343-4996, JieYing.Wu@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Task accuracy (e.g., resection precision) (time frame: within 90 minutes of AR-guided use). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.