- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07686211
Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task (SPeAR)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 초기 1단계
연락처 및 위치
연구 연락처
- 이름: Jie Ying Wu Assistant Professor of Computer Science, PhD
- 전화번호: 615-343-4996
- 이메일: JieYing.Wu@vanderbilt.edu
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37232
- 모병
- Vanderbilt University Medical Center
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연락하다:
- Jie Ying Wu Assistant Professor of Computer Science, PhD
- 전화번호: 615-343-4996
- 이메일: JieYing.Wu@vanderbilt.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 인구
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Non-physician surgery providers.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 장치 타당성
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Performance Task accuracy (e.g., resection precision)
기간: within 90 minutes of AR-guided use
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Surgeon performance of target re-localization compared with and without the AR-headset.
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within 90 minutes of AR-guided use
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User Experience
기간: immediately after the AR-guided task.
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Assess AR usability, ease of use, and comfort, through surgeon feedback surveys
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immediately after the AR-guided task.
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Accuracy of overlay alignment
기간: within 90 minutes of completing the AR-guided task.
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This will validate the accuracy of overlay alignment through landmark-based (tumor margin relocation) error metrics, which support precision of re-resection tasks.
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within 90 minutes of completing the AR-guided task.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael Topf, MD, Vanderbilt University Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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