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

No results posted yet for this study

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

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489678 on ClinicalTrials.gov