Clinical trial · Interventional
Robotic Bronchoscopy for Peripheral Pulmonary Lesions
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study
NCT03727425CI-TRIAL-00048822completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung; Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic assisted bronchoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Robotic assisted bronchoscopy
- description
- Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.
- interventionNames
- Device: Robotic assisted bronchoscopy
Primary outcomes (2)
- measure
- Number of Participants With Device or Procedure Related Adverse Events
- timeFrame
- 24-84 hours post-procedure
- description
- Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
- measure
- Successful Navigation to Targeted Peripheral Pulmonary Lesions
- timeFrame
- During the procedure, approximately 1 hour
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Capable and willing to give informed consent 2. Acceptable candidate for an elective, non-emergent bronchoscopic procedure 3. 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 4. Lack bleeding disorders Exclusion Criteria: 1. Medical contraindication to bronchoscopy 2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT 3. Patients with endobronchial involvement seen on chest CT 4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure 5. Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study 6. Uncontrolled or irreversible coagulopathy 7. Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test 8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement
References
Publications (1)
- DERIVEDChen AC, Pastis NJ Jr, Mahajan AK, Khandhar SJ, Simoff MJ, Machuzak MS, Cicenia J, Gildea TR, Silvestri GA. Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study (BENEFIT). Chest. 2021 Feb;159(2):845-852. doi: 10.1016/j.chest.2020.08.2047. Epub 2020 Aug 19. PMID 32822675