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Apple Vision Pro-Assisted Vascular Identification in Lung Surgery (AVP-Lung)

1. mai 2026 oppdatert av: Xiaohua Zuo, The Second People's Hospital of Huai'an

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Chuxu Wang, Attending Physician
  • Telefonnummer: +86 15996195616
  • E-post: wangchuxu@qq.com

Studer Kontakt Backup

  • Navn: Bo Min, Associate Professor
  • Telefonnummer: +86 18851392328
  • E-post: doctor_min@163.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experimental
Participants in this arm will undergo lung surgery using Apple Vision Pro for intraoperative vascular navigation
Enhet: Apple Vision Pro
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of Perivascular Anatomical Identification
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Second People's Hospital of Huai'an

Etterforskere

  • Hovedetterforsker: Chuxu Wang, Attending Physician, The Second People's Hospital of Huai'an

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. juli 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

1. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HEYLL202654

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

This is a single-center study with a limited sample size and specific local protocol. Due to resource constraints and the focus on immediate clinical outcomes for this specific cohort, data sharing is not planned at this time.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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