Lung Cancer, Lung Diseases, Pulmonary Nodule
Conditions
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.
Interventions
DEVICEIon Endoluminal System™
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.
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Complications | Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure |
Countries
United States
Outcome results
None listed