Clinical Utility for Ion Endoluminal System

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System (Ion) for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.

Official Title
-----------------
PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System

Conditions
-----------------
Pulmonary Nodule, Lung Cancer, Lung Diseases

Intervention / Treatment
-----------------
* Device: Ion Endoluminal System™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and older Patient is suitable for elective bronchoscopy Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus* Patients are candidates for CT-guided needle biopsy and/or surgical resection Patient able to understand and adhere to study requirements Patient able to understand and adhere to study requirements and able to provide informed consent Patient not legally incapacitated or in legal/court ordered institution Patients with no dependency on the investigator or sponsor Exclusion Criteria: Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e.> 30 breaths per minute) per physician assessment) Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C) World Health Organization functional Class III or Class IV Pulmonary Hypertension or history of clinically significant mPAP Lung abscess Known or suspected pregnancy Recent head injury (<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness) Subjects with pure ground glass opacity target nodule Inability to adequately oxygenate subject during procedure per physicians discretion (i.e. unable to achieve S02 > 92% or requiring >4L of oxygen prior to procedure) Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 4 Subjects taking antiplatelet (i.e. clopidogrel), anti-coagulant (i.e heparin or warfarin) or platelet aggression inhibitors (i.e. Abciximab or Eptifibatide) medications that cannot be stopped per standard practice, i.e. 5-7 days pre-procedure or heparin that cannot be held according to standard practice (6-12 hours). Aspirin not included. Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy (i.e. >Stage 3 heart failure) Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician Endobronchial lesion associated with lobar atelectasis Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA) Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s) Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s) Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robotic Bronchoscopy<br>The Ion™ Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. | Device: Ion Endoluminal System™<br>* The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigation Success |  | Day 1 (Time of Procedure) | 
| Biopsy Success |  | Day 1 (Time of Procedure) | 
| Sensitivity for Malignancy of System-Obtained Sample |  | 14 months Post-Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure |