An interventional study of Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules and CT-Guided Percutaneous Localization of Pulmonary Nodules in Pulmonary Nodules and Early-Stage Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Treatment
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.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 400 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules
Procedure: CT-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 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.
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.
Time frame: Day 0 (Intraoperative)
Localization Accuracy
The shortest physical distance (unit: mm) between the actual localization marker point (e.g., the center of the dye) and the outer edge of the nodular lesion in the resected specimen.
Time frame: Day 0 (Intraoperative)
Location Procedure Time
CT-guided group: Time from the start of the initial localization planning CT scan to the completion of marker/needle deployment and withdrawal of instruments from the body surface. Electromagnetic navigation group: Time from when the bronchoscope passes the vocal cords to the completion of marker deployment and withdrawal of the guiding instrument (unit: min).
Time frame: Day 0 (Intraoperative)
Conversion Rate
The proportion of subjects in whom conversion from complete thoracoscopy to thoracotomy, or from the planned sublobar resection (wedge/segment) to an extended resection (e.g., lobectomy), was necessitated due to failure to locate the lesion, insufficient surgical margin resulting from excessive localization error, or severe complications related to localization (such as major hemorrhage).
Time frame: Day 0 (Intraoperative)
Complication Rate
Record the incidence of all complications related to the localization procedure. In addition to complications common to percutaneous approaches, such as pneumothorax and intrathoracic hemorrhage, airway-related complications, including airway mucosal injury/bleeding, bronchospasm, and severe hypoxemia, should be systematically documented. Assessment should be performed based on the adverse event grading criteria.
Time frame: Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
Radiation Exposure
Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm).
Time frame: Day 0 (Intraoperative)
Operative Time
Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).
Time frame: Day 0 (Intraoperative)
Early Postoperative Pain Score
Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), scored from 0 to 10 points (with 0 representing no pain and 10 representing the most severe pain).
Time frame: Day 0 (immediately after localization); 24 hours postoperatively
Plan to share: Undecided
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Pulmonary Hospital, Shanghai, China →