NCT07573748

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026Jul 2026

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 24, 2026

Last Update Submit

May 1, 2026

Conditions

Keywords

Lung NeoplasmsMixed realityIntraoperative NavigationThree-Dimensional Imaging

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Perivascular Anatomical Identification

    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

Study Arms (1)

Experimental

EXPERIMENTAL

Participants in this arm will undergo lung surgery using Apple Vision Pro for intraoperative vascular navigation

Device: Apple Vision Pro

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 41403068BACKGROUND
  • 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.

    PMID: 40679982BACKGROUND
  • 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.

    PMID: 39525735BACKGROUND
  • 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.

    PMID: 39308843BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chuxu Wang, Attending Physician

    The Second People's Hospital of Huai'an

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuxu Wang, Attending Physician

CONTACT

Bo Min, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, prospective study. All participants will undergo standard-of-care lung surgery with the addition of the Apple Vision Pro mixed-reality headset for intraoperative vascular navigation. There is no control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 7, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.