Clinical trial NCT06335563: Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules
Official title: Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Nodule
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group
Primary purpose: TREATMENT

Brief summary: This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.

Detailed description: This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.

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.

Primary outcomes:
measure: Accuracy of puncture localization of pulmonary nodules
timeFrame: Intraoperative
Secondary outcomes:
measure: Success rate of puncture localization of pulmonary nodules
timeFrame: Intraoperative
measure: Adjust the number of needle punctures
timeFrame: Intraoperative
measure: Operating time
timeFrame: Intraoperative
measure: Radiation dose
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, School of Medicine, Tongji University
name: Deping Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: