Pulmonary NodulesNCT07595120
Application of Electromagnetic Navigation System in Pulmonary Nodule Localization
A study testing Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules and CT-Guided Percutaneous Localization of Pulmonary Nodules in people with Pulmonary Nodules and Early-Stage Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodules, Early-Stage Lung Cancer
- What is being tested?
- Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules and CT-Guided Percutaneous Localization of Pulmonary Nodules
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Pulmonary Hospital
Shanghai
Haifeng Wang, +8602156561656, huangshplus5@163.com
About this study
Official title: Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial
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.
- Conditions
- Pulmonary Nodules, Early-Stage Lung Cancer
- Being tested
- Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules, CT-Guided Percutaneous Localization of Pulmonary Nodules
- Keywords
- ENB, CT-guided Percutaneous, pulmonary nodules, localization
- Medical subject headings
- Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary NodulesProcedure or surgery
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.
CT-Guided Percutaneous Localization of Pulmonary NodulesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic Navigation Localization Group | Experimental | Not described Receives: Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules |
| CT-Guided Localization Group | Active comparator | Not described Receives: Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (Intraoperative)
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Day 0 (Intraoperative)
Operative Time
Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).
Measured: 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).
Measured: Day 0 (immediately after localization); 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haifeng Wang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Haifeng Wang, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595120
- Sponsor's protocol ID
- IRB-K26-427
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07595120
- Acronym / sponsor ID
- IRB-K26-427
- Conditions
- Pulmonary Nodules, Early-Stage Lung Cancer
- Keywords
- ENB, CT-guided Percutaneous, pulmonary nodules, localization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic Navigation Localization Group | Experimental | Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules |
| CT-Guided Localization Group | Active comparator | Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary NodulesPerformed 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. | Procedure or surgery | Electromagnetic Navigation Localization Group |
| CT-Guided Percutaneous Localization of Pulmonary NodulesPerformed 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. | Procedure or surgery | CT-Guided Localization Group |
Primary outcome
Success rate of intraoperative localization of lung nodules
Time frame: Day 0 (Intraoperative)
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haifeng Wang principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules and CT-Guided Percutaneous Localization of Pulmonary Nodules in people with Pulmonary Nodules and Early-Stage Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenghao Huang (+86 153 5656 1656, huangshplus5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of intraoperative localization of lung nodules (time frame: Day 0 (Intraoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.