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

NCT07500818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-30

No results posted yet for this study

Summary

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

  • Interstitial Lung Disease (ILD)
  • Lung Biopsy

Interventions

PROCEDURE

Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance

Robotic-assisted bronchoscopy using a shape-sensing robotic platform with cone-beam CT confirmation of biopsy location. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.

PROCEDURE

Conventional Bronchoscopy With Fluoroscopy Guidance

Flexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.

Sponsors & Collaborators

  • Cantonal Hospital of Lucerne, Switzerland

    collaborator UNKNOWN

  • University Hospital, Zürich

    collaborator OTHER

  • University of Zurich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-02-01
Completion
2027-09-01

Countries

  • Switzerland

Study Locations

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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 NCT07500818 on ClinicalTrials.gov