Actively Recruiting

Phase Not Applicable
All Genders
NCT07500818

Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Led by University of Zurich · Updated on 2026-03-30

30

Participants Needed

2

Research Sites

82 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

C

Cantonal Hospital of Lucerne, Switzerland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Interstitial lung disease (ILD) often requires histopathological confirmation when high-resolution computed tomography (HRCT) findings are inconclusive. Transbronchial lung cryobiopsy has emerged as a less invasive alternative to surgical lung biopsy, but diagnostic yield remains variable and dependent on biopsy location and procedural precision. Robotic-assisted bronchoscopy (RAB) combined with cone-beam computed tomography (CBCT) may allow more precise navigation to target lung segments and potentially improve biopsy quality and diagnostic yield. This multi-center, investigator-initiated randomized controlled trial will compare conventional bronchoscopy with 2D fluoroscopy guidance versus robotic-assisted bronchoscopy with CBCT guidance for transbronchial lung cryobiopsy in patients undergoing diagnostic evaluation for suspected interstitial lung disease. Participants will be randomized in a 1:1 ratio to undergo either conventional bronchoscopy or robotic-assisted bronchoscopy. In both groups, four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe (en-bloc removal for both study arms). The primary endpoint is the rate of definitive histological diagnosis as determined by a blinded multidisciplinary ILD board.

CONDITIONS

Official Title

Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical suspicion of interstitial lung disease requiring histological confirmation
  • Non-diagnostic high-resolution CT pattern (e.g., probable UIP or indeterminate pattern)
  • Candidate for transbronchial lung cryobiopsy
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Definite usual interstitial pneumonia (UIP) pattern on high-resolution CT
  • Severe pulmonary hypertension
  • Severe hypoxemia that contraindicates bronchoscopy
  • Coagulopathy or any contraindication to biopsy
  • Pregnancy
  • Inability to provide informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Cantonal Hospital of Lucerne

Lucerne, Canton of Lucerne, Switzerland, 6000

Actively Recruiting

2

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

T

Thomas Gaisl, MD MPH PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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