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Application of a High-Precision Electromagnetic Navigation System in the Localization of Pulmonary Nodules: A Randomized Controlled Clinical Trial

Application of a High-Precision Electromagnetic Navigation System in the Localization of Pulmonary Nodules: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123635
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Electromagnetic Navigation Group:Transfer patient's pulmonary CT data into medical imaging workstation and reconstruct three-dimensional bronchial tree
perform white light bronchoscopy and navigation system registration after anesthesia
intraoperatively guide the advancement of guided sheath (GS) to target lesion in real time using electromagnetic navigation
remove positioning wire, leave GS in place to establish an extended working channel, and position locator to complete localization.
Conventional CT Guidance Group:General anesthesia in prone position
perform initial scanning and planning with 6s DynaCT Body at end-inspiration breath-hold
under three-dimensional laser guidance, insert localization needle into the patient's chest cavity, project planned virtual needle trajectory onto real-time fluoroscopic images to adjust direction and

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years, any gender; 2. Chest CT (lung window), maximum nodule diameter <=2 cm; 3. ECOG performance status 0-2; 4. Planned VATS wedge resection or segmentectomy, with intended percutaneous or bronchoscopic localization of pulmonary nodules; 5. Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The distance between the center of the lesion and the top of the diaphragm is less than 3 cm. 2. The lesion is adjacent to the hilum of the lungs or major blood vessels; 3. Pleural adhesions caused by a history of thoracotomy or pleural infection; 4. Patients who, as determined by the researcher, are not suitable for preoperative positioning through the chest wall or bronchi; 5. It is not suitable for video-assisted thoracoscopic surgery.

Design outcomes

Primary

MeasureTime frame
Success rate of pulmonary nodule puncture localization;

Secondary

MeasureTime frame
Accuracy of puncture localization;Incidence rate of complications after puncture localization;Procedure duration;Radiation dose;Early postoperative pain score;

Countries

China

Contacts

Public ContactWang Haifeng

Shanghai Pulmonary Hospital

huangshplus5@163.com+86 181 0196 5307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026