Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).

Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.

Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.

Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

Standard FB with fluoroscopy

Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

R-EBUS with ultrathin bronchoscope

Nichole T Tanner, MD, M.S.C.R

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.

This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions

Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.

Olympus

Johns Hopkins University

Medstar Health Research Institute

Mayo Clinic

Washington University School of Medicine

Medical University of South Carolina

Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX).

Standard FB with fluoroscopy: Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions

Standard FB With Fluoroscopy

Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.

Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX.

R-EBUS with ultrathin bronchoscope: Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions

R-EBUS With Ultrathin Bronchoscope

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Kate Taylor

Diagnostic

Non-Diagnostic

Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions

Overall Study

Solitary Pulmonary Nodule

Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System

The iNod™ Ultrasound Imaging System enables visualization of endobronchial lesions, peripheral lung nodules, or lung masses (referred to as lesions) using R-EBUS and performance of lung biopsy under direct R-EBUS visualization.

iNod™ System

Alexander Chen, MD

The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.

This post-market study intends to further demonstrate the ability and safety of the iNod™ Ultrasound Guidance System and iNod™ Ultrasound Biopsy needle to perform transbronchial needle biopsy of endobronchial lesions, peripheral lung nodules, or lung masses under real-time ultrasound visualization. This is a prospective, multi-center case series of standard of care peripheral lung nodule biopsy procedures with up to 115 subjects at up to 10 centers.

iNod™ Ultrasound-Guided Needle Biopsy System Study

Prospective Multi-center Study Using a Bronchoscopic Ultrasound-Guided Needle Biopsy System With Real-time Visualization in Endobronchial Lesions, Peripheral Lung Nodules, or Lung Masses

Diagnostic biopsy yield, defined as ability for histopathologist to report a specific benign or malignant diagnosis, stratified by concentric and eccentric lesion location.

Ability to reposition the needle into a different location within targeted lesions, if desired.

Crossover rate to radial EBUS or any alternative standard of care procedure.

Successful "Tool in lesion", defined as visualization of the tracheobronchial biopsy needle (TBNA) inside the targeted lesion within the ultrasound field of view.

Proportion of subjects with Adverse Events related to the iNod device and/or study procedure, as well as Adverse Events related to any subsequent crossover procedures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )	NCT02146131	Pulmonary Lesio... Pulmonary Nodul... Pulmonary Mass	Standard FB wit... R-EBUS with ult...	22 Years -	Medical University of South Carolina
iNod™ Ultrasound-Guided Needle Biopsy System Study	NCT05804435	Solitary Pulmon... Multiple Pulmon... Biopsy, Fine-Ne...	iNod™ System	18 Years -	Boston Scientific Corporation

Spots Global Cancer Trial Database for pulmonary lesions