Apple Vision Pro-Assisted Vascular Identification in Lung Surgery (AVP-Lung)
Apple Vision Pro-Assisted Vascular Identification in Lung Surgery: A Prospective Interventional Study
This study is testing whether a new mixed-reality head-mounted display (Apple Vision Pro) can help surgeons see blood vessels more clearly during lung surgery.
During the operation, doctors usually need to identify and protect important blood vessels to avoid bleeding. In this study, surgeons will wear the Apple Vision Pro device, which shows 3D images of the lungs and blood vessels. This may help them find vessels more accurately and make surgery safer.
Participants scheduled for lung surgery at Huai'an Second People's Hospital will be invited to join. Before the operation, participants will have a CT scan. During surgery, doctors will use the device while performing the procedure.
The study does not change the standard surgical steps, and there are no extra risks for participants. The main goal is to see if this new technology makes surgery easier and safer.
Participation is voluntary, and all personal information will be kept confidential.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Precise identification of pulmonary blood vessels is critical in thoracic surgery to prevent intraoperative bleeding and complications. Conventional methods rely on direct visual inspection and preoperative imaging review. Recent advances in extended reality (XR) technology offer potential for real-time, three-dimensional visualization during surgery.
Objective:
This study aims to evaluate the feasibility and safety of using Apple Vision Pro, a mixed-reality head-mounted display, to assist surgeons in identifying and navigating blood vessels during lung surgery.
Methods:
This is a single-center, prospective clinical study conducted at Huai'an Second People's Hospital. Patients undergoing elective lung surgery will be enrolled. All participants will receive standard preoperative chest CT scans.
During surgery, the surgical team will use Apple Vision Pro to visualize reconstructed 3D vascular models superimposed on the surgical field. The primary outcome is the accuracy of vessel identification and navigation. Secondary outcomes include operative time, blood loss, complication rates, and surgeon feedback on usability.
Ethical Considerations:
The study protocol has been approved by the Medical Ethics Committee of Huai'an Second People's Hospital. Informed consent will be obtained from all participants prior to enrollment.
Significance:
If successful, this study may provide a novel technological approach to improving surgical precision and safety in thoracic surgery.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chuxu Wang, Attending Physician
- Número de teléfono: +86 15996195616
- Correo electrónico: wangchuxu@qq.com
Copia de seguridad de contactos de estudio
- Nombre: Bo Min, Associate Professor
- Número de teléfono: +86 18851392328
- Correo electrónico: doctor_min@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Patients aged 18 years or older. Diagnosed with lung nodules or early-stage lung cancer requiring surgical resection (lobectomy or segmentectomy).
Scheduled for elective lung surgery at Huai'an Second People's Hospital. American Society of Anesthesiologists (ASA) Physical Status Classification I-III.
Ability to understand and sign the informed consent form. Willingness to undergo surgery with the Apple Vision Pro navigation assistance.
Exclusion Criteria:
Patients under 18 years of age. Pregnant or breastfeeding women. Patients with severe cardiopulmonary dysfunction (e.g., severe COPD, unstable angina, recent myocardial infarction) that would contraindicate surgery.
Participation in another interventional clinical trial within the past 30 days. Inability to cooperate with the surgical team or follow study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental
Participants in this arm will undergo lung surgery using Apple Vision Pro for intraoperative vascular navigation
|
Use of Apple Vision Pro headset for augmented reality-assisted surgical navigation during lung surgery.
The device will be worn by the surgeon to visualize critical anatomical structures and navigation pathways in real-time.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Accuracy of Perivascular Anatomical Identification
Periodo de tiempo: During the critical dissection and transection phase of lung surgery
|
The primary outcome is the accuracy of identifying critical perivascular anatomical structures (including pulmonary arteries, veins, and bronchi) using Apple Vision Pro.
Accuracy will be measured by comparing the real-time navigation display with the actual anatomy confirmed by the surgeon during dissection.
The primary endpoint is the successful identification of the correct transection plane that avoids injury to adjacent arteries, veins, or bronchi.
Any discrepancy leading to potential mis-transection will be recorded.
|
During the critical dissection and transection phase of lung surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chuxu Wang, Attending Physician, The Second People's Hospital of Huai'an
Publicaciones y enlaces útiles
Publicaciones Generales
- Zhou AE, Klufas T, Feng H. Leveraging Apple Vision Pro for Dermatologic Surgery Education and Intraoperative Recording. Indian Dermatol Online J. 2026 Mar 1;17(2):294-295. doi: 10.4103/idoj.idoj_692_25. Epub 2025 Dec 12. No abstract available.
- Shen K, Li W, Xie Z. Preliminary application of Apple Vision Pro (AVP) in laparoscopic gastrointestinal surgery. Int J Surg. 2025 Nov 1;111(11):7898-7905. doi: 10.1097/JS9.0000000000003066. Epub 2025 Jul 17.
- Li C. Apple Vision Pro as an augmentative tool in surgery: a double-edged scalpel. Ann Med Surg (Lond). 2024 Oct 11;86(11):6407-6408. doi: 10.1097/MS9.0000000000002645. eCollection 2024 Nov. No abstract available.
- Shanbhag NM, Bin Sumaida A, Al Shamisi K, Balaraj K. Apple Vision Pro: A Paradigm Shift in Medical Technology. Cureus. 2024 Sep 17;16(9):e69608. doi: 10.7759/cureus.69608. eCollection 2024 Sep.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HEYLL202654
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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