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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Chuxu Wang, Attending Physician
- Numer telefonu: +86 15996195616
- E-mail: wangchuxu@qq.com
Kopia zapasowa kontaktu do badania
- Nazwa: Bo Min, Associate Professor
- Numer telefonu: +86 18851392328
- E-mail: doctor_min@163.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Accuracy of Perivascular Anatomical Identification
Ramy czasowe: 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
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Chuxu Wang, Attending Physician, The Second People's Hospital of Huai'an
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HEYLL202654
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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