NCT06489678

Benefit of Cone-beam CT and Robotic-assisted Bronchoscopy During Bronchoscopy

The Benefit of Cone-beam Computed Tomography and Robotic Assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Lesions and Other Lung Disease Requiring Lung Biopsy: an Open-label, Randomized, Controlled Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound. The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB . Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.

Conditions

• Lung Neoplasms
• Diagnosis
• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-10-01
• Completion: 2027-07-30
• First posted: 2024-07-08
• Last updated: 2024-11-01

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study