Using augmented reality glasses to locate small lung nodules before surgery

Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial

This study tests whether using augmented reality glasses can help doctors find small lung nodules more accurately before surgery compared to the usual CT scans.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06335563 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of augmented reality (AR) glasses in assisting with the preoperative localization of small pulmonary nodules compared to traditional CT guidance. It is a randomized controlled trial conducted at the Pulmonary Hospital Affiliated to Tongji University, where patients scheduled for percutaneous puncture localization will be randomly assigned to either the AR glasses-assisted group or the conventional CT-guided group. The primary goal is to assess the accuracy and safety of the AR-assisted method in locating these nodules. The study aims to demonstrate that the AR approach is at least as effective as the traditional method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with small pulmonary nodules suitable for wedge resection.

Not a fit: Patients with lesions in difficult locations or those with significant anatomical challenges may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the precision and safety of lung nodule localization, potentially leading to better surgical outcomes.

How similar studies have performed: While the use of augmented reality in medical procedures is emerging, this specific application for pulmonary nodule localization is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80, no gender limit;
2. Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
3. Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
4. Physical condition score ECOG 0-2 points;
5. If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
6. Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

1. The lesion is located in front of the scapula, and the needle path is blocked;
2. The distance between the center of the lesion and the top of the diaphragm is \< 3 cm;
3. The lesion is adjacent to the hilus or large blood vessels;
4. Pleural adhesions caused by a history of thoracotomy or pleural infection;
5. The patient voluntarily withdraws midway.

Where this trial is running

Shanghai, Shanghai

• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Deping Zhao, MD, PhD — Shanghai Pulmonary Hospital, School of Medicine, Tongji University
• Study coordinator: Yunlang She, MD

Conditions Pulmonary Nodule