None listed
Conditions
Brief summary
This study is a prospective, single-arm, single-centre, first-in-human clinical investigation evaluating the safety and feasibility of a new bronchoscopic ultrasound system for the survey and sampling of mediastinal and hilar lymph node stations in patients with confirmed or suspected lung cancer. Who is it for? You may be eligible for this study if you are aged 21 years or older and have a confirmed diagnosis of lung cancer or have been assessed by the Investigator as having a high clinical suspicion and indicated for staging lung cancer. Study details In this Phase 2 study, all participants will be sedated and undergo a standard bronchoscopic procedure. Survey and Sampling of lymph node stations will be conducted using the investigational device. Follow-up visits will be at 1-week, 30 days and 3 months post-procedure (chart review only). All participants are monitored for adverse events and outcomes related to the procedure and device through 30 days post procedure. It is hoped that findings from this study will help researchers and clinicians determine whether use of this new system is safe and feasible.
Interventions
This clinical investigation is a prospective, single-arm, single-centre, first-in-human study designed to evaluate the safety and feasibility of a new endobronchial ultrasound system for the survey and sampling of mediastinal and hilar lymph node stations.
The procedure is intended for patients with confirmed or suspected lung cancer who require lymph node staging; lymph node staging is a commonly performed and guideline recommended procedure to further characterize a patient’s lung cancer dis
This clinical investigation is a prospective, single-arm, single-centre, first-in-human study designed to evaluate the safety and feasibility of a new endobronchial ultrasound system for the survey and sampling of mediastinal and hilar lymph node stations. The procedure is intended for patients with confirmed or suspected lung cancer who require lymph node staging; lymph node staging is a commonly performed and guideline recommended procedure to further characterize a patient’s lung cancer disease state. Conventional methods are performed using a manual bronchoscope (i.e., manual endobronchial ultrasound guided transbronchial-guided needle aspiration [EBUS-TBNA]) The study uses a new bronchoscopic ultrasound system, which integrates a live camera and ultrasound imaging to support the survey and sampling of lymph nodes. The Lymph node stations of Phase 2 participants will be surveyed and biopsied/sampled using the investigational device. All procedures are performed under general anaesthesia. The device is inserted via an airway access device and moved through the lungs by the physician according to navigation guidance provided by the study device to relevant lymph node stations for survey and sampling. The order and overall workflow of node assessment/sampling is at the clinician’s discretion. The Investigator may use conventional endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) to complete sampling if instances occur in which the investigational device is unable to sample clinically indicated nodes/stations. Rapid on-site evaluation (ROSE) will be performed for all collected samples and will specify which device the sample was obtained from. The full study procedure is expected to last approximately 30 mins to one hour. The procedure will take place in the bronchoscopy suite performed by qualified physicians which is similar to the practice for conventional lymph node staging and sampling. Representatives of the device manufacturer will be observing the procedure and will provide technical guidance regarding use of the device if needed. Participants will be followed up at 1 week, 30 days and 3 months following the procedure by the study team. At the 1 week and 30-day follow-up visits the physician will discuss the results with patients and will review their medical records. At the 3-month follow-up visit, medical records will be reviewed to understand if any other interventions for lung cancer were performed during this period. Adverse events will be collected through 30-days post procedure.
Sponsors
Ascend Clinical Research Organization, Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is greater than or equal to 21 years old 2. Subjects must have a confirmed diagnosis of lung cancer or be assessed by the Investigator as having a high clinical suspicion and indicated for staging lung cancer
Exclusion criteria
1. Subjects with known significant pulmonary conditions, including but not limited to interstitial pneumonia, severe and symptomatic Chronic Obstructive Pulmonary Disease (COPD), diffuse symptomatic fibrosis of the lungs, severe respiratory failure, and/or pulmonary arterial hypertension, or those requiring home oxygen. 2. Subjects with severe cardiovascular conditions (such as myocardial infarction within 6 months of the procedure or uncontrolled cardiac arrhythmia) or severe cerebrovascular conditions (such as a history of stroke or Transient Ischemic Attack (TIA) within 6 months of the procedure). 3. Subjects with confirmed stage IV primary lung cancer prior to the start of the study procedure. Subjects with current or active systemic infections, including acute viral, fungal, or bacterial diagnoses.
Outcome results
None listed