Pulmonary NodulesNCT07743775
CT-Free Electromagnetic Navigation Percutaneous Localization for Pulmonary Nodules Undergoing Sublobar Resection
An observational study of Pulmonary Nodules and Early-Stage Lung Cancer, run by Jianle Chen at 3 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodules, Early-Stage Lung Cancer
- How many people
- 153 participants
- Where
- 3 sitesChina
- Study dates
- 24 Jun 2025to 28 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Nantong First People's Hospital
Nantong, Jiangsu
Nantong Sixth People's Hospital
Nantong, Jiangsu
Nantong University Affiliated Hospital
Nantong, Jiangsu
About this study
Official title: 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.
- Conditions
- Pulmonary Nodules, Early-Stage Lung Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm
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.
Measured: Immediately after surgical resection
Secondary outcomes (5)
Proportion of Participants Requiring Additional Localization Procedures
The proportion of participants requiring additional localization methods because of unsuccessful or inaccurate initial localization.
Measured: During surgery
Number of Participants With Procedure-Related Complications
Procedure-related complications including pneumothorax, pulmonary hemorrhage, and infection occurring after localization and surgery.
Measured: Within 30 days after surgery
Duration of Pulmonary Nodule Localization Procedure
The duration from initiation of localization preparation to completion of marker placement.
Measured: From initiation to completion of the localization procedure
Mean Distance Between Localization Marker and Pulmonary Nodule Center (mm)
The mean distance between the localization marker and the pulmonary nodule center measured immediately after surgical specimen resection.
Measured: Immediately after surgical specimen resection
Mean Duration of Postoperative Hospital Stay
The mean duration of hospitalization after surgical resection, calculated from the date of surgery to the date of hospital discharge.
Measured: Up to 30 days after surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start24 Jun 2025
- Primary completion28 Mar 2026
- Study completion28 Mar 2026
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianle Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianle Chen, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743775
- Sponsor's protocol ID
- 2025-K079
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of CT-Free Electromagnetic Navigation Percutaneous Localization System for Pulmonary Nodules Undergoing Sublobar Resection: A Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07743775
- Acronym / sponsor ID
- 2025-K079
- Conditions
- Pulmonary Nodules, Early-Stage Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Jianle ChenUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 4 Aug 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Proportion of Participants Requiring Additional Localization Procedures
Time frame: During surgery
Number of Participants With Procedure-Related Complications
Time frame: Within 30 days after surgery
Duration of Pulmonary Nodule Localization Procedure
Time frame: 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
Mean Duration of Postoperative Hospital Stay
Time frame: Up to 30 days after surgical resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodules and Early-Stage Lung Cancer, run by Jianle Chen at 3 sites 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 4 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: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Successful Localization Based on Marker-to-Nodule Distance ≤10 mm (time frame: Immediately after surgical resection). 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 4 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.