Clinical Utility for Ion Endoluminal System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Robotic Bronchoscopy 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™
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Complications [Intra-procedure, Immediately Post-Procedure, Day 10 Post-Procedure, Day 30 Post-Procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 years and older
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Patient is suitable for elective bronchoscopy
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Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
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Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension
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Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus*
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Patients are candidates for CT-guided needle biopsy and/or surgical resection
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Patient able to understand and adhere to study requirements
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Patient able to understand and adhere to study requirements and able to provide informed consent
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Patient not legally incapacitated or in legal/court ordered institution
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Patients with no dependency on the investigator or sponsor
Exclusion Criteria:
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Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
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Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
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Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
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Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e.> 30 breaths per minute) per physician assessment)
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Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
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World Health Organization functional Class III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
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Lung abscess
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Known or suspected pregnancy
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Recent head injury (<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
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Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)
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Subjects with pure ground glass opacity target nodule
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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)
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Subject with uncorrectable coagulopathy, bleeding or platelet disorders, history of major bleeding with bronchoscopy
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Subjects contraindicated for intubation or general anesthesia, or subjects with ASA ≥ 4
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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.
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Any severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy (i.e. >Stage 3 heart failure)
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Moderate-to-severe pulmonary fibrosis presenting procedural risk as assessed by physician
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Endobronchial lesion associated with lobar atelectasis
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Presence of bullae >1cm located within a cone based trajectory of biopsy instruments or in location presenting risk per physician assessment
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Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
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Subjects taking the following medications: Immunosuppressive treatment with systemic azathioprine, Cyclosporine, antibodies or cytostatics, other chemotherapeutic agents or medications acting on immunophilins
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Non-systemic treatment for lung cancer (i.e. SBRT, ablation) performed in the same lobe as the target nodule(s)
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Previous surgical intervention (i.e. wedge resection or lobectomy) within the same lobe as target nodule (s)
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Participation in any interventional clinical study or clinical study with experimental agents or agents of unknown risk in last 30 days prior to screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Beth Israel Deaconness Medical Center | Boston | Massachusetts | United States | 02215 |
| 3 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 4 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 5 | FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | United States | 28374 |
| 6 | MD Anderson Cancer Center | Houston | Texas | United States | 77054 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
- Study Chair: Erik Folch, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISI-ION-001-2018