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NCT Number: NCT07743775

CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection

Pulmonary nodules, particularly small and non-palpable nodules, present challenges for accurate localization during sublobar lung resection. This multicenter observational cohort study evaluated the feasibility, accuracy, and safety of CT-Free electromagnetic navigation percutaneous localization for pulmonary nodules requiring sublobar resection.

Patients who underwent CT-Free electromagnetic navigation localization were compared with patients who received conventional CT-guided localization. The primary outcome was localization success rate, defined as the distance between the localization marker and the pulmonary nodule center being within 10 mm.

Secondary outcomes included localization procedure time, conversion rate to other localization methods, surgical success rate, perioperative complications, postoperative hospitalization duration, and medical resource utilization.

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Key information

Conditions

Pulmonary Nodules Early-Stage Lung Cancer Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantong First People's Hospital, Nantong, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older.
  • Patients with pulmonary nodules requiring sublobar resection.
  • Non-palpable pulmonary nodules requiring preoperative localization.
  • Patients undergoing CT-Free electromagnetic navigation localization or CT-guided localization.

Exclusion criteria

  • Central pulmonary nodules unsuitable for localization.
  • Patients unable to undergo sublobar resection.
  • Patients with severe cardiopulmonary dysfunction or major organ dysfunction.
  • Pregnancy or breastfeeding.
  • Patients participating in other clinical trials.

Treatment and study plan

Primary outcomes

  1. Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm

    Time frame: Immediately after surgical resection

    The proportion of participants with successful pulmonary nodule localization, defined as a distance between the localization marker and the pulmonary nodule center of ≤10 mm, measured by postoperative pathological specimen evaluation.

Secondary outcomes

  1. Proportion of Participants Requiring Additional Localization Procedures

    Time frame: During surgery

    The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.

  2. Number of Participants With Procedure-Related Complications

    Time frame: Within 30 days after surgery

    Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.

  3. Duration of Pulmonary Nodule Localization Procedure

    Time frame: From initiation to completion of the localization procedure

    The duration from initiation of localization preparation to completion of marker placement.

  4. Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)

    Time frame: Immediately after surgical specimen resection

    The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.

  5. Mean Duration of Postoperative Hospital Stay

    Time frame: Up to 30 days after surgical resection

    The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge.

Sponsors and collaborators

Lead sponsor

Jianle Chen

Other

Registry information

Official study title

Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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