Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

ENB is used in this group.EBUS and GS are inserted into bronchi in the assistance of ENB. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

ENB isn't used in this group.EBUS and GS are inserted into bronchi according to the chest CT that judged by the doctor. The EBUS probe and GS are confirmed to reach the lesion by EBUS images.

ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

EBUS-GS

Jiayuan Sun, MD,PhD

Jiayuan Sun, MD, PhD

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.

The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.

ENB in the Diagnosis of Peripheral Pulmonary Nodules

Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules

Diagnostic yield is defined as proportion of true positive and true negative.

The operation time includes total operation time,total GS time and total EBUS time

Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Air Force Military Medical University, China

Xiangya Hospital of Central South University

Shanghai Chest Hospital

Director, Department of Endoscopy

To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).

Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.

Navigation guided bronchoscopy

Lonny Yarmus, DO

The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).

Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.

Patients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.

Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy

Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot

Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)

Presence of pneumothorax assessed in participants with successful completion of biopsy.

Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.

Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.

Veran Medical Technologies

Johns Hopkins University

To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).

Navigation guided bronchoscopy

Assessing Peripheral Pulmonary Nodules

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Lonny Yarmus

Feasibility

Incidence of Pneumothorax

Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone

Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB

To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).

Navigation guided bronchoscopy

Overall Study

The patients whose chest CT images show that the pulmonary nodules are highly suspected of malignant and scheduled to be diagnosed by bronchoscopy under the guidance of the Augmented Reality Navigation System.

Investigators will assess the nodules based on the CT images of subjects before procedure. And then, the appropriate intra-airway path planned by the Augmented Reality Navigation System will be selected. The bronchoscopy with intra-airway navigation under the guidance of the Augmented Reality Navigation System will be performed and the following surgical information will be record.

Augmented Reality Navigation System

Shiyue Li, MD,PhD

The study is designed to evaluate the efficacy and safety of Augmented Reality Navigation System through intra-airway navigation system to guide bronchoscopy in the diagnosis of peripheral pulmonary nodules and explore the factors of diagnosis yield.

This is a single-arm, prospective, Asian multicenter, Real World case Registry study. Recruitment is expected to last up to 12 months, and each subject may be followed up for 12 months at most after surgery which depends on certain factors. The total duration of the study is about 24 months.The research is planned to be carried out at more than 10 sites.

Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules

A Real World Case Registry Study to Evaluate Augmented Reality Navigation System for Diagnosis of Peripheral Pulmonary Nodules

It is defined as the percentage of patients who get definitive diagnosis via bronchoscope biopsy guided by intra-airway navigation system.

It is defined as the percentage of nodules with successful biopsy.

It is defined as the percentage of nodules whose arrival is confirmed by endobronchial ultrasound (and/or fluoroscopy, or direct bronchoscopy).

It is defined as the total time from the beginning of navigation to the end of navigation.

It is defined as the total time of bronchoscope insertion to bronchoscope withdrawal.

Hong Kong Sanatorium & Hospital

Guangzhou Institute of Respiratory Disease

Professor

This research study involves a screening period, a procedure and follow up visits

* Procedure Visit Navigation Bronchoscopy Alone
* Follow-Up Visits at Week 1, 4 and 12

This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules

-Follow-Up Visits at Week 1, 4 and 12

Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.

Navigation Bronchoscopy

Cone beam computed tomography (CBCT)

Adnan Majid, MD

The purpose of this study is to determine if the cone beam computed tomography (CBCT)-guided navigation bronchoscopy is better in diagnosing lung nodules compared to navigation bronchoscopy alone.

This clinical trial examines the effectiveness of a treatment comparing it to another known treatment.

The U.S. Food and Drug Administration (FDA) has approved the navigation bronchoscopy as a treatment option for this disease.

The U.S. Food and Drug Administration (FDA) has approved the Cone-Beam CT scan as a treatment option for this disease.

This research study involves a screening period, a procedure and follow up visits.

The names of the study interventions involved in this study are:

* Computed tomography (CBCT)-guided navigation bronchoscopy (CBCT-guided NB)
* Navigation bronchoscopy alone

Participants will receive the study procedure and will be followed for up to 6 months.

It is expected that about 136 people will take part in this research study.

CBCT-Guided Navigational Bronchoscopy For Lung Nodules

Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules: A Randomized Trial

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The overall diagnostic yield will be calculated by adding the number of true positives (TP) for both malignancy and benign disease in the numerator and dividing by the total number of procedures performed for each arm of the study.

Proportions will be compared with the Chi-Square Test as this test is equivalent to the z-test of two proportions (26). A p-value \<0.05 will be considered as statistically significant.

To compare complications between navigational bronchoscopy alone and CBCT guided bronchoscopy.

To compare the need of additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.

To compare the navigational time defined as the time between the start of catheter driving after registration until catheter is parked for biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB in the Diagnosis of Peripheral Pulmonary Nodules	NCT03569306	Peripheral Pulm...	ENB EBUS-GS	18 Years -	Shanghai Chest Hospital
Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy	NCT02109458	Peripheral Pulm...	Navigation guid...	18 Years - 99 Years	Johns Hopkins University
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules	NCT04740606	Lung; Node	Augmented Reali...	18 Years -	Guangzhou Institute of Respiratory Disease
Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy	NCT02109458	Peripheral Pulm...	Navigation guid...	18 Years - 99 Years	Johns Hopkins University
Airway Navigation Database Asia for Diagnosis of Peripheral Pulmonary Nodules	NCT04740606	Lung; Node	Augmented Reali...	18 Years -	Guangzhou Institute of Respiratory Disease
ENB in the Diagnosis of Peripheral Pulmonary Nodules	NCT03569306	Peripheral Pulm...	ENB EBUS-GS	18 Years -	Shanghai Chest Hospital
CBCT-Guided Navigational Bronchoscopy For Lung Nodules	NCT04758403	Peripheral Pulm... Lung; Node Cone Beam Compu... Guided Navigati...	Navigation Bron... Cone beam compu...	18 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for peripheral pulmonary nodules