Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
NCT06489678 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-05-05
Summary
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.
Conditions
- Lung Neoplasms
- Diagnosis
- Lung Cancer
Interventions
- DIAGNOSTIC_TEST
-
Robotic Assisted Bronchoscopy
Cone-beam computed tomography (CBCT) technology and robotic-assisted bronchoscopy (RAB) present promising methods to enhance biopsy accuracy and procedural safety through 3-dimensional reconstructions and increased bronchoscope tip flexibility. Additionally, the transfer of navigational data between CBCT and RAB may further improve diagnostic yield. Given their distinct approaches to enhancing diagnostic outcomes, two separate study arms are warranted for CBCT and RAB.
Sponsors & Collaborators
-
University of Zurich
lead OTHER
Principal Investigators
-
Thomas Gaisl, MD MPH PhD · University of Zurich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-25
- Primary Completion
- 2025-10-01
- Completion
- 2027-07-30
- FDA Device
- Yes
Countries
- Switzerland
Study Locations
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