Application of Electromagnetic Navigation System in Pulmonary Nodule Localization

Shanghai Pulmonary Hospital, Shanghai, China

Status: Not yet enrolling

Conditions: Early-Stage Lung Cancer; Pulmonary Nodules

Treatments: Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules; Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules

Study type: Interventional

Funder types: Other

Identifiers

NCT07595120

IRB-K26-427

Details and patient eligibility

About

This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80 years, regardless of gender;
2. Solitary single nodule, scheduled for lung nodule puncture and localization;
3. Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm;
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
5. Voluntary participation, with signed informed consent.

Exclusion criteria

1. Not suitable for video-assisted thoracoscopic surgery;
2. The distance between the center of the lesion and the dome of the diaphragm is < 3 cm;
3. History of thoracic adhesion due to previous thoracotomy or pleural infection;
4. Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization;
5. Inability to complete follow-up or poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Electromagnetic Navigation Localization Group

Experimental group

Treatment:

Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules

CT-Guided Localization Group

Active Comparator group

Treatment:

Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules