Clinical trial NCT06056128: Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Nodes, Lung
Keywords: Lung cancer, robotic assisted bronchoscopy
Lead sponsor: Noah Medical
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. 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
3. 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
4. Pre-procedural CT is conducted within 90 days of the bronchoscopy procedure
5. PPNs that are accessible bronchoscopically on planning CT reconstruction
6. Informed consent properly obtained per local regulations

Exclusion Criteria:

1. Known pregnancy or breastfeeding
2. Patients with pure ground-glass nodules on pre-procedural chest CT
3. Uncontrolled coagulopathy or bleeding disorders
4. Ongoing systemic infection
5. History of lobectomy or pneumonectomy
6. Patient is participating in another drug or device trial or participated in another drug or device trial in the last 30 days.
7. Moderate-to-severe hypoxia, hypoxemia, or hypercarbia per PI's discretion
8. Patients with pacemakers or defibrillators
9. Unsuitable for bronchoscopy procedure under general anaesthesia as agreed by the treating clinician and anaesthetist

Primary outcomes:
measure: Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
timeFrame: During the procedure
measure: Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
timeFrame: Up to 7 days post-procedure
Secondary outcomes:
measure: Diagnostic yield
timeFrame: Between 7 days and 6 months post-procedure
measure: Center strike as confirmed by CBCT
timeFrame: During the procedure
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong, Prince of Wales Hospital
name: Calvin Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: