- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07743775
CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection
Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nantong, Jiangsu, China
- Nantong First People's Hospital
-
Nantong, Jiangsu, China
- Nantong Sixth People's Hospital
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Nantong, Jiangsu, China
- Nantong University Affiliated Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
CT-Free Electromagnetic Navigation Localization
Patients receiving CT-Free electromagnetic navigation percutaneous localization before sublobar resection for pulmonary nodules.
|
|
CT-Guided Localization
Patients receiving conventional CT-guided localization before sublobar resection for pulmonary nodules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately after surgical resection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During surgery
|
|
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.
|
Within 30 days after surgery
|
|
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.
|
From initiation to completion of the localization procedure
|
|
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.
|
Immediately after surgical specimen resection
|
|
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.
|
Up to 30 days after surgical resection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-K079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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