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A prospective observational study evaluating the accuracy of the tool-in-lesion technology of the Galaxy SystemTM in normal clinical practice.
The goal of this study is to collect clinical data from eligible subjects in routine clinical practice to confirm the safety and effectiveness of the Galaxy SystemTM with integrated tool-in-lesion tomography (TiLT+) in bronchoscopically biopsying small peripheral pulmonary nodules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/Treatment | Subjects who undergo bronchoscopy of the airways using the Galaxy System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted bronchoscopy | Device | Subjects will undergo a robotic navigated bronchoscopy to biopsy peripheral pulmonary nodules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Navigation to the lesion | Placing the scope in an adequate location which the physician operator judges as suitable to initiate biopsy. | During the procedure |
| Successful tool-in-lesion | Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT. | During the procedure |
| Serious Adverse Events | Serious device or procedure related adverse events | During the procedure and 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. | End of procedure and up to 2-years post-procedure |
| Center Strike |
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Inclusion Criteria:
Exclusion Criteria:
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Clinic patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Memorial Hospital | Chattanooga | Tennessee | 37404 | United States | ||
| Inova Fairfax Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41620189 | Derived | Mahajan AK, Duong DK, Cortes J, Bhadra K. The match 2 study: Robotic assisted bronchoscopy with integrated imaging with assessment of digital tomosynthesis (DT) and augmented fluoroscopy (AF): Three-Dimensional accuracy as confirmed by cone beam computed tomography (CBCT). Respir Med. 2026 Mar;253:108693. doi: 10.1016/j.rmed.2026.108693. Epub 2026 Jan 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 16, 2026 | |
| Reset | May 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2026 | May 6, 2026 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Center strike (defined as inner one-third of lesion from all 3 views (axial, sagittal, and coronal) confirmed by CBCT.
| During the procedure |
| Falls Church |
| Virginia |
| 22042 |
| United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |