First Human Use of an Investigational Bronchoscope System - Assessing Safety and Performance

Completed

• Conditions: Pulmonary Nodules of Unknown Etiology; Respiratory - Other respiratory disorders / diseases; Cancer - Lung - Small cell; Cancer - Lung - Non small cell

• Registration Number: ACTRN12616001185459
• Lead Sponsor: Intuitive Surgical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified