Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Robotic assisted bronchoscopy

Septimiu Murgu, MD

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.

Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.

A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.

Individual components of the primary endpoint

Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer

Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples

Auris Health, Inc.

Alexander Chen, MD

Gerard A Silvestri, MD

Thomas R Gildea, MD

Amit K Mahajan, MD

Michael J Simoff, MD

In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.

Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.

Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.

Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.

Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.

Determined from the results of the bronchoscopy.

Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Robotic assisted bronchoscopy: Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Robotic Assisted Bronchoscopy

Age, Continuous

Sex: Female, Male

Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Scott Rehage

54 patients underwent the robotic bronchoscopy procedure

Number of Participants With Device or Procedure Related Adverse Events

Radial probe endobronchial ultrasound was available in 53/54 cases.

Successful Navigation to Targeted Peripheral Pulmonary Lesions

Incidence of Complications Unrelated to Device

Time to R-EBUS Confirmation (Lesion Localization)

Total Procedure Time

Diagnostic Yield

Overall Study

Robotic assisted bronchoscopy procedures performed using the Galaxy System.

Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions

Ami Shah

Song Liu

Calvin Ng, MD

This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.

Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology

Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study

Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.

Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.

Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung	NCT04182815	Pulmonary Nodul... Lung Cancer	Robotic assiste...	21 Years -	Auris Health, Inc.
Robotic Bronchoscopy for Peripheral Pulmonary Lesions	NCT03727425	Lung; Node	Robotic assiste...	18 Years - 80 Years	Auris Health, Inc.
Robotic Bronchoscopy for Peripheral Pulmonary Lesions	NCT03727425	Lung; Node	Robotic assiste...	18 Years - 80 Years	Auris Health, Inc.
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology	NCT06056128	Lung Cancer Nodes, Lung	Robotic assiste...	18 Years -	Noah Medical
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung	NCT04182815	Pulmonary Nodul... Lung Cancer	Robotic assiste...	21 Years -	Auris Health, Inc.

Spots Global Cancer Trial Database for robotic assisted bronchoscopy