Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Ion Endoluminal Procedure for pulmonary nodule

Ion Endoluminal System

Glen Bouder, MD

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)

Sensitivity for malignancy of the sample obtained

Incidence of all pneumothoraces related to the Ion procedure

Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.

All adverse events related to the Ion procedure

Rate of procedures converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., electromagnetic navigational bronchoscopy\] or a different procedure \[ex., CT-guided transthoracic needle aspiration\]) after the Ion catheter has entered the endotracheal tube. Termination is defined as prematurely ending the procedure after the Ion catheter has entered the endotracheal tube but before the biopsy sample has been obtained.

Intuitive Surgical

Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.

Subjects will under a planned procedure with the Ion Endoluminal System

Heather Golden, MSc, CCRP

Lindsay Seibel, BSc

Tina Tham, CCRP

Chinh Phan, DO

Kathleen Sanders, MBA, CCRP

Ali Z. Jiwani, MD

Diana Sullivan, MS, RN

Neeraj Desai, MD

Jamie Quigley, RRT, CCRC

Maykol Postigo, MD

Sherae Hereford, RN

A. Rolando Peralta, MD

Karly Pierson, RN, CCRP

Janani Reisenauer, MD

Iulia Basaraba, MD

Bradley Icard, DO

Julie Williams, PhD, MPH

Michael Prichett, DO, MPH

Amy Miller

Alberto Revelo, MD

Sean O'Malley, RN, BSN

Susan Garwood, MD

Samantha Franklin

Ali Abedi, MD, MSc

Valerie Aston, MBA, CCRP

Timothy LeClair, MD

Dina Yassen, MBBS

Hasnain Bawaadam, MD, MPH

Michael Pritchett, DO, MPH

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.

Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Real World Registry for Use of the Ion Endoluminal System

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.

Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale

Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion

Ion Endoluminal dye marking procedure for pulmonary nodule

The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample

Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube \[ETT\]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT).

Time from start of resection procedure to end of resection procedure (skin-to-skin time)

The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started.

Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., open resection\] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed.

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Carcinoma

Carcinoma, Non-Small-Cell Lung

Solitary Pulmonary Nodule

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

Pulmonary nodule is suitable for elective bronchoscopy with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease.

Evaluate the clinical utility and early performance of the Cios 3D Mobile Spin in conjunction with the Ion Endoluminal System, to visualize and facilitate the sampling of pulmonary nodules between 1-3 cm via the airway.

Cios Mobile 3D Spin for Robotic Bronchoscopy

Ability to visualize on 3D imaging the pre-planned target location characterized when displayed distance of catheter tip to nearest edge of the virtual target is ≤ 2cm and is oriented towards the lesion in 3 axes.

Overall incidence of procedure-related complications recorded as adverse events.

Reporting of times related to procedure times including procedure time, navigation time, time to 3D confirmation, time to tissue acquisitions, anesthesia time, and fluoroscopy time and dose.

Siemens Corporation, Corporate Technology

Mayo Clinic

Principal Investigator

ION™ Endoluminal System Providers will utilize the ION™ Endoluminal System to perform a diagnostic bronchoscopy procedure

Providers will utilize the superDimension Navigation System and Accessories to perform a diagnostic bronchoscopy procedure.

Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

superDimension Navigation System and Accessories

Yueping Qian, Ph.D.

Jiyuan Sun, M.D.

Yuanlin Song, M.D.

Dan Liu

Dan Liu, M.D.

Jiayuan Sun, M.D.

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.

Lung cancer is the malignant tumor with the highest morbidity and mortality in the world. Besides the aggressive nature of lung cancer, the overall high cancer mortality is mainly associated with the time delay between cancer development and initial clinical symptoms.

In the past, bronchoscope was mainly used to biopsy the nodules in the central airway but played a limited role in managing peripheral nodules due to its low diagnosis accuracy in such nodules. Advanced bronchoscopic techniques include tools for bronchoscopic guidance such as guide sheath (GS), Endobronchial Ultrasound (EBUS), Electromagnetic Navigation (ENB), or Virtual Bronchoscopic Navigation (VBN). In well-designed clinical studies, these techniques can be used to increase the diagnostic yield of flexible bronchoscope in dealing with peripheral nodules. However, the real-world registry study data showed that the diagnostic yield of these techniques in practice is as low as 53.7 %.. More importantly, these advanced bronchoscopic techniques haven't been widely used or become standard treatments in China mainly due to high skill requirements and high costs.

ION™ Endoluminal System is a robotic-assisted system which assists the user in navigating a catheter and endoscopic tools in the pulmonary tract under bronchial endoscope for diagnostic and therapeutic procedures. The fully articulating catheter with a small outer diameter of 3.5 mm can enter the small airways around the lungs with navigation enabled by shape-sensing technology and not electromagnetics; the shape sensing fiber provides instant feedbacks on shapes and locations during navigation and biopsy. The tool channel with an inner diameter of 2 mm for the catheter is compatible with various biopsy tools.

The purpose of this study a randomized controlled study to test the hypothesis that the diagnostic yield of ION™ is Superior to electromagnetic navigation bronchoscopy in patients undergoing bronchoscopy to biopsy a peripheral pulmonary nodule (PPN).

Stratified, randomized controlled trial with parallel group assignment

Pathologist reviewing biopsy results will be blinded

A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

A Randomized Controlled Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

Diagnostic yield=number of study procedures in which a true positive for malignancy or a specific benign result is diagnosed by biopsy or non-specific benign is confirmed at the follow-up 6 months after procedure/total number of study procedures of each group ×100 %

Diagnostic sensitivity of malignancies=number of cases diagnosed with malignancies by study procedure / number of causes with malignancies in each group \* 100 %

Pneumothorax is graded according to CTCAE 5.0. and differentiated according to the necessity to place a chest tube, readmission to the hospital, or prolonged hospitalization.

Severe airway bleeding is defined as Grade 3 or above per Nashville Delphi scale (2020).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions	NCT05160571	Lung Cancer Pulmonary Nodul...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Real World Registry for Use of the Ion Endoluminal System	NCT06004440	Lung Cancer Multiple Pulmon... Lung Neoplasms Respiratory Tra... Thoracic Neopla... Neoplasms by Si... Neoplasms Lung Diseases Respiratory Tra...	Ion Endoluminal...	18 Years -	Intuitive Surgical
A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System	NCT05546437	Lung Cancer	Ion Endoluminal...	18 Years -	Intuitive Surgical
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions	NCT05160571	Lung Cancer Pulmonary Nodul...	Ion Endoluminal...	18 Years -	Intuitive Surgical
Cios Mobile 3D Spin for Robotic Bronchoscopy	NCT04740047	Pulmonary Nodul... Pulmonary Cance... Lung Cancer Lung Cancer, No... Lung Adenocarci...	Ion Endoluminal...	18 Years -	Mayo Clinic
A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB	NCT06308120	Pulmonary Nodul... Lung Cancer	Ion Endoluminal... superDimension ...	18 Years - 80 Years	Intuitive Surgical

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