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

NCT06489678 | Active Not Recruiting FDA Device

• 1 other identifier: BASEC Nr. 2024-00684
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Keywords

Cone-beam CT; Robotic assisted Bronchoscopy; Cios Spin; Ion endoluminal System; Advanced Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  ATS 2024 consensus criteria

  Including a 12-month follow-up (clinical data)

Secondary Outcomes (5)

• Radiation exposure

  During Intervention

• Safety profile

  During Intervention

• Diagnostic accuracy for milignancy

  Including a 12-month follow-up (clinical data)

• Quality of biopsies

  During Intervention

• Navigation success

  During Intervention

Other Outcomes (1)

• Procedure Duration

  During Intervention

Study Arms (2)

Usual Care

NO INTERVENTION

For the control arm, standard bronchoscopy (±virtual or electromagnetic navigation, r-EBUS, and 2-dimensional fluoroscopy) will be employed, using various types of bronchoscopes (±ultra-thin bronchoscopes) and biopsy tools (needle, cryoprobe, forceps) at the investigator's discretion.

Cone-beam CT and robotic assisted bronchoscopy

ACTIVE COMPARATOR

Usual care with Cone-beam CT and the added option for the use of robotic assisted bronchoscopy (Ion endoluminal System, Intuitive) during the procedure. A connection between the cone-beam CT and the robotic system (NaviLink) is also possible.

Diagnostic Test: Robotic Assisted Bronchoscopy

Interventions

Robotic Assisted Bronchoscopy DIAGNOSTIC_TEST

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.

Also known as: Cios Spin (Siemens) and Ion endoluminal system (Intuitive)

Cone-beam CT and robotic assisted bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18 years
• Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
• Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
• Informed consent

You may not qualify if:

• Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
• Previous randomization to an arm of the present trial
• Endobronchial lesion causing lobar atelectasis
• Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
• Pregnant or lactating women
• For nested RCTs (Trial A + B):
• A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan)
• B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring \>3 cm in diameter of the short axis and/or with an interstitial pattern)

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Gaisl, MD MPH PhD

  University of Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: June 25, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)