ENB for the Diagnosis of PPNs:a Real World Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

479 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-20

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ENB in the Diagnosis of Peripheral Pulmonary Nodules

NCT03569306

Peripheral Pulmonary Nodules

UNKNOWN NA

ENB-GS-TBLB for the Diagnosis of PPLs

NCT02207478

Lung Cancer

COMPLETED NA

Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules

NCT01779388

Pulmonary Nodule Cm

COMPLETED NA

Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

NCT04597346

Peripheral Pulmonary Lesion

UNKNOWN

mCBCT in Combination With ENB for the Diagnosis of PPNs

NCT05518669

Peripheral Pulmonary Nodules Lung Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Pulmonary Nodules

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electromagnetic navigation bronchoscopy (ENB)

ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who are older than 18 year-old.
2. Chest CT shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria

1. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
2. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No