Actively Recruiting

Phase Not Applicable
All Genders
ID07500818

Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in Diagnosing Interstitial Lung Disease: A Randomized Controlled Trial

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

30

Participants Needed

2

Research Sites

30 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) is a group of lung conditions often needing tissue samples for diagnosis when imaging results are unclear. This study compares two methods for obtaining lung biopsies: traditional bronchoscopy guided by 2D fluoroscopy versus robotic-assisted bronchoscopy combined with cone-beam CT (CBCT) guidance. The goal is to see if the robotic method improves the accuracy of diagnosis by better targeting lung areas for biopsy. Participants will be randomly assigned to one of two groups. One group will undergo robotic-assisted bronchoscopy using a robotic platform with CBCT to confirm biopsy locations, while the other will have conventional bronchoscopy with fluoroscopy guidance. Both groups will have four cryobiopsies taken from two different lung lobes using a 1.7 mm cryoprobe. Samples will be reviewed by a blinded multidisciplinary team to determine diagnostic accuracy. During the study, participants will undergo the assigned biopsy procedure followed by evaluation of the tissue samples. Researchers will assess the rate of definitive histological diagnosis as the primary outcome. Secondary outcomes include biopsy size, tissue composition, and safety within 24 hours after the procedure. The study is sponsored by the University of Zurich and plans to enroll adult patients suspected of having ILD who require biopsy confirmation.

CONDITIONS

Brief 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 HRCT pattern such as probable UIP or indeterminate pattern
  • Candidate for transbronchial lung cryobiopsy
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Definite UIP pattern on HRCT
  • Severe pulmonary hypertension
  • Severe hypoxemia contraindicating bronchoscopy
  • Coagulopathy or contraindication to biopsy
  • Pregnancy
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day of procedure

Participants undergo either robotic-assisted bronchoscopy with cone-beam CT guidance or conventional bronchoscopy with fluoroscopy guidance to obtain lung biopsies for diagnosis.

1 procedure visit (in-person)

Post-procedure Follow-up

Duration - Up to 24 hours post procedure

Participants are monitored for safety and any complications up to 24 hours after the biopsy procedure.

1 follow-up visit (in-person) within 24 hours

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

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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