Application of Electromagnetic Navigation System in Pulmonary Nodule Localization
Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial
1 other identifier
interventional
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
1 active site
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 Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
May 19, 2026
May 1, 2026
8 months
May 5, 2026
May 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success rate of intraoperative localization of lung nodules
Thoracoscopic exploration enables accurate identification and localization of markers (e.g., contrast dye, microcoils, etc.), with the distance between the center of the marker or the main imaging area and the center of the target nodule being ≤20 mm, and ultimately successfully guides the resection of the target lesion.
Day 0 (Intraoperative)
Secondary Outcomes (7)
Localization Accuracy
Day 0 (Intraoperative)
Location Procedure Time
Day 0 (Intraoperative)
Conversion Rate
Day 0 (Intraoperative)
Complication Rate
Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
Radiation Exposure
Day 0 (Intraoperative)
- +2 more secondary outcomes
Study Arms (2)
Electromagnetic Navigation Localization Group
EXPERIMENTALCT-Guided Localization Group
ACTIVE COMPARATORInterventions
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 percutaneous puncture to accurately place a positioning guidewire / microcoil / dye near the target pulmonary nodule; 4) postoperative CT scan to confirm the localization. This is a single-session procedure.
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) performing a repeat CT scan post-procedure to confirm the localization position. This is a single-session procedure.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haifeng Wang
Shanghai Pulmonary Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 19, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
May 19, 2026
Record last verified: 2026-05