NCT07743775

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 19, 2026

Last Update Submit

July 29, 2026

Conditions

Pulmonary NodulesEarly-Stage Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after surgical resection

Secondary Outcomes (5)

  • Proportion of Participants Requiring Additional Localization Procedures

    During surgery

  • Number of Participants With Procedure-Related Complications

    Within 30 days after surgery

  • Duration of Pulmonary Nodule Localization Procedure

    From initiation to completion of the localization procedure

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

    Immediately after surgical specimen resection

  • Mean Duration of Postoperative Hospital Stay

    Up to 30 days after surgical resection

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pulmonary nodules requiring preoperative localization before sublobar lung resection at multiple participating centers.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nantong First People's Hospital

Nantong, Jiangsu, China

Location

Nantong Sixth People's Hospital

Nantong, Jiangsu, China

Location

Nantong University Affiliated Hospital

Nantong, Jiangsu, China

Location

MeSH Terms

Conditions

Multiple Pulmonary NodulesLung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Chief Physician

Study Record Dates

First Submitted

July 19, 2026

First Posted

August 4, 2026

Study Start

June 24, 2025

Primary Completion

March 28, 2026

Study Completion

March 28, 2026

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)