Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489678
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 3 study army 3x46 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 nested randomized controlled trials RCTs for specific lesion types targeting 3x46 lesions for 3 study arms i usual care ii added CBCT and iii CBCT and RAB
Primary endpoints include procedure time for the overall trial and diagnostic yield ATS 2024 criteria for the nested RCTs analyzed via Pearsons 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 studys recruitment phase spans 24 months with a 12-month follow-up running from July 2024 to July 2027
The trial will involve 300 participants in the overall observational study with nested randomized controlled trials RCTs for specific lesion types targeting 3x46 lesions for 3 study arms i usual care ii added CBCT and iii CBCT and RAB
Primary endpoints include procedure time for the overall trial and diagnostic yield ATS 2024 criteria for the nested RCTs analyzed via Pearsons 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 studys recruitment phase spans 24 months with a 12-month follow-up running from July 2024 to July 2027
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None