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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic assisted bronchoscopy | Experimental | Robotic assisted bronchoscopy procedures performed using the Galaxy System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted bronchoscopy | Device | Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Calvin Ng, MD | Chinese University of Hong Kong, Prince of Wales Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong, Prince of Wales Hospital | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.
| During the procedure |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |