None listed
Conditions
Brief summary
First human use clinical trial of an investigational (not-approved) study device used to facilitate the biopsy of pulmonary nodules with unknown etiology. The purpose of this study is to evaluate the safety and feasibility/performance of the investigational device - up to 30 subjects will be enrolled, and will be followed-up for up to 6 months post-procedure. For non-malignant subjects, data may be collected from a standard of care follow-up visit at 12 months post-procedure
Interventions
Subjects will be screened according to study specific criteria to determine if eligible for the trial. After undergoing pre-procedure assessments which are standard of care for this type of procedure, the subject will be treated according to standard of care, but utilizing the study device under investigation by a trained physician with robust experience in performing bronchoscopy or other pulmonary interventions. The study device is a robotic-assisted bronchoscope system, which is an alternativ
Subjects will be screened according to study specific criteria to determine if eligible for the trial. After undergoing pre-procedure assessments which are standard of care for this type of procedure, the subject will be treated according to standard of care, but utilizing the study device under investigation by a trained physician with robust experience in performing bronchoscopy or other pulmonary interventions. The study device is a robotic-assisted bronchoscope system, which is an alternative to a conventional bronchoscope. The approximate duration of the procedure is approximately 1 hour. Subjects will be monitored prior to discharge and undergo a post-procedure chest x-ray to check for any complications. Subjects are then required to visit their study doctor at 7-days post-procedure for results of the diagnostic intervention and for a general health assessment, and will also undergo a phone or office visit at 90 and 180 day post procedure. Subjects with a non-malignant finding may have data collected from a standard of care follow-up visit at 12 months post-procedure.
Sponsors
Intuitive Surgical
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) Patients suitable for surgery or intervention, aged 18 years - 75 years 2) Pulmonary nodule(s) (PN) due to suspected lung cancer or metastatic disease or nodule(s) of unknown etiology that require further diagnostic evaluation 3) One or more soft tissue dominant pulmonary nodules between (and including) 10mm and 30 mm in largest dimension on axial plane 4) Nodule completely surrounded by at least 5 mm lung parenchyma, does not touch the hilum or mediastinum, is not associated with adenopathy, atelectasis, or pleural effusion, and the proximal nodule margin (leading edge facing the bronchus & catheter) is more than 1.5 cm distant to the visceral pleura 5) Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information using risk prediction algorithms (as described in the review article of Lam and Tammemagi) 6) PN accessible bronchoscopically on planning CT reconstruction (within 3 cm proximity to PN) 7) Patient able to understand and adhere to study requirements 8) Patient able to provide and sign informed consent 9) Patient not legally incapacitated
Exclusion criteria
1) An inability to tolerate bronchoscopy under endotracheal intubation and general anesthesia. 2) ASA class greater than or equal to 3 3) PN touches the pulmonary hilum or mediastinum, or is associated with adenopathy, lobar atelectasis, or pleural effusion 4) Central PN’s located within the first 3 airway generations (segmental airways, B1-10) 5) The airway leading to the target lesion arises from an aberrant accessory tracheal bronchus 6) Continuous use of anticoagulants (eg, heparin, warfarin) or antiplatelet agents (e.g. Cyclooxygenase Inhibitors (Aspirin), ADP-Receptor inhibitors (Clopidogrel), GP-IIB/IIIA- inhibitors (Abciximac), fish oil, etc) which cannot be discontinued. 7) Uncorrectable coagulopathy or bleeding diathesis 8) Platelet dysfunction or platelet count less than 100×10 to the 9th power 9) History of major bleeding with bronchoscopy 10) Pulmonary hypertension with mean Pulmonary Arterial Pressure (PAP) greater than 25 mm 11) Moderate-to-severe pulmonary fibrosis 12) Severe respiratory insufficiency or hypoxia, moderate-to-severe hypoxemia or any degree of hypercarbia 13) One or more bullae greater than 1 cm located in close vicinity (less than 1cm) of target PN 14) Giant bullae within the same lobe of the target PN 15) Partial tracheal obstruction or obstruction of the superior vena cava 16) Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy for example: 16a) greater than Stage 3 heart failure (NY-Heart Failure Classification) 16b) Unstable hemodynamic status including 16c) Uncontrolled dysrhythmias 16d) History of ventricular arrhythmias 16e) Uncontrolled Hypertension (Blood Pressure systolic greater than 200mmHg, Blood Pressure diastolic greater than 120mmHg) 16f) Unstable Angina 16g) Myocardial infarction within 6 months 16h) Severe cachexia, debility and malnutrition 16i) Acute Renal or Liver Failure 17) Ongoing systemic acute or chronic infection 18) Pneumonia or acute bronchitis within 3 month of the procedure 19) Lung abscess 20) White Blood Cell (WBC) Count less than 2000 or greater than 20,000 21) Recent head injury or increased intracranial pressure 22) Contraindication to general anesthesia 23) Exposure to radiation treatment or chemotherapy within 3 months prior to the IROB procedure 24) Participation in any other study in last 30 days 25) Prior thoracic surgery on the same side of the lung as the PN or pneumonectomy of the contralateral lung 26) Patients who are pregnant or lactating 27) Patients with known intrapulmonary metastases of extrapulmonary cancer/tumors 28) Persons with any kind of dependency on the investigator or employed by the sponsor or investigator 29) Persons held in an institution by legal or official order, or part of vulnerable population (i.e. mentally disabled) 30) Known allergy, sensitivity or previous allergic reaction to ortho-phthalaldehyde (OPA)
Outcome results
None listed