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Not yet recruiting NCT07595120

Application of Electromagnetic Navigation System in Pulmonary Nodule Localization

No phase Interventional Pulmonary Nodules Early-Stage Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules, CT-Guided Percutaneous Localization of Pulmonary Nodules.
Who it may be relevant to
Registry conditions: Pulmonary Nodules, Early-Stage Lung Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial

Overview

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.

Interventions

  • Procedure Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules
    Performed by an experienced thoracic surgeon or interventional radiologist under general or local anesthesia, the procedure is guided by an electromagnetic navigation system. The procedural steps include: 1) preoperative import of the patient's CT data into the navigation system for path planning; 2) intraoperative coupling of the positioning sensor with the puncture instrument; 3) under real-time three-dimensional imaging guidance of the electromagnetic navigation system, performing percutaneou
  • Procedure CT-Guided Percutaneous Localization of Pulmonary Nodules
    Performed by an experienced thoracic surgeon or interventional radiologist under local anesthesia, the procedure is guided using a CT scanner. The steps include: 1) positioning the patient appropriately and performing a CT scan to determine the puncture site and path; 2) employing CT fluoroscopy or intermittent CT scanning for real-time guidance; 3) under CT image guidance, performing a percutaneous puncture to place a localization guidewire / microcoil / dye near the target pulmonary nodule; 4)

Primary outcome measures

  • Success rate of intraoperative localization of lung nodules [Time frame: Day 0 (Intraoperative)]
Secondary outcome measures (7)
  • Localization Accuracy [Time frame: Day 0 (Intraoperative)]
  • Location Procedure Time [Time frame: Day 0 (Intraoperative)]
  • Conversion Rate [Time frame: Day 0 (Intraoperative)]
  • Complication Rate [Time frame: Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first]
  • Radiation Exposure [Time frame: Day 0 (Intraoperative)]
  • Operative Time [Time frame: Day 0 (Intraoperative)]
  • Early Postoperative Pain Score [Time frame: Day 0 (immediately after localization); 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07595120 · IRB-K26-427

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗