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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Time Frame: During the procedure
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.
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Time Frame: Up to 7 days post-procedure
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Secondary Outcomes
- Diagnostic yield(Between 7 days and 6 months post-procedure)
- Center strike as confirmed by CBCT(During the procedure)