Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology

Study Overview
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Brief Summary
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This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.

Detailed Description
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Successful biopsy of peripheral pulmonary lesions continues to be a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. In this study, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.

Official Title
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Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology in Human Subjects to Bronchoscopically Biopsy Small Peripheral Pulmonary Nodules: TiLT Study

Conditions
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Lung Cancer, Nodes, Lung

Intervention / Treatment
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* Device: Robotic assisted bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information, determined by the treating physicians based on the site's standard of care Peripheral pulmonary subsolid and solid nodules (PPNs) sized 1-3 cm measured as the largest dimension where all or the majority of the lesion is located in the periphery of the lung Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure PPNs that are accessible bronchoscopically on planning CT reconstruction Informed consent properly obtained per local regulations Exclusion Criteria: Known pregnancy or breastfeeding Patients with pure ground-glass nodules on pre-procedural chest CT Uncontrolled coagulopathy or bleeding disorders Ongoing systemic infection History of lobectomy or pneumonectomy Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion Patients with pacemakers or defibrillators Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted bronchoscopy<br>Robotic assisted bronchoscopy procedures performed using the Galaxy System. | Device: Robotic assisted bronchoscopy<br>* Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT. | Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed. | During the procedure | 
| Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure | Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure. | Up to 7 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue. | Between 7 days and 6 months post-procedure | 
| Center strike as confirmed by CBCT | Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy. | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, robotic assisted bronchoscopy