N/A
Completed N=55
Robotic Bronchoscopy for Peripheral Pulmonary Lesions
Lung; Node
Source: ClinicalTrials.gov NCT03727425 ↗
Enrolled (actual)
55
Serious AEs
3.6%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Device or Procedure Related Adverse Events — 2 Participants
Summary
In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Device or Procedure Related Adverse Events |
2 | — |
| PRIMARY Successful Navigation to Targeted Peripheral Pulmonary Lesions |
51 | — |
| SECONDARY Incidence of Complications Unrelated to Device |
— | — |
| SECONDARY Time to R-EBUS Confirmation (Lesion Localization) |
13 | — |
| SECONDARY Total Procedure Time |
51 | — |
| SECONDARY Diagnostic Yield |
40 | — |
Eligibility Criteria
Inclusion Criteria
- Capable and willing to give informed consent
- Acceptable candidate for an elective, non-emergent bronchoscopic procedure
- Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
- Lack bleeding disorders
Exclusion Criteria
- Medical contraindication to bronchoscopy
- Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
- Patients with endobronchial involvement seen on chest CT
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
- Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
- Uncontrolled or irreversible coagulopathy
- Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
- Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement
Data sourced from ClinicalTrials.gov (NCT03727425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.