NCT07500818

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Sep 2027

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 18, 2026

Last Update Submit

March 24, 2026

Conditions

Interstitial Lung Disease (ILD)Lung Biopsy

Keywords

Robotic-assisted BronchoscopyCryobiopsyCBCTInterventional PulmonologyInterstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Histological Diagnosis

    Rate of Definitive Histological Diagnosis

    Perioperative/Periprocedural

Secondary Outcomes (3)

  • Biopsy Size

    Perioperative/Periprocedural

  • Tissue Composition of Biopsies

    Perioperative/Periprocedural

  • Safety Composite

    Up to 24 hours post procedure

Other Outcomes (2)

  • Radiation Exposure

    Perioperative/Periprocedural

  • Procedure Duration

    Perioperative/Periprocedural

Study Arms (2)

Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance

EXPERIMENTAL

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: Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance

Conventional Bronchoscopy With Fluoroscopy Guidance

ACTIVE COMPARATOR

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

Procedure: Conventional Bronchoscopy With Fluoroscopy Guidance

Interventions

Robotic-Assisted Bronchoscopy With Cone-Beam CT GuidancePROCEDURE

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.

Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance
Conventional Bronchoscopy With Fluoroscopy GuidancePROCEDURE

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

Conventional Bronchoscopy With Fluoroscopy Guidance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Clinical suspicion of interstitial lung disease requiring histological confirmation
  • Non-diagnostic HRCT pattern (e.g. probable UIP or indeterminate pattern)
  • Candidate for transbronchial lung cryobiopsy
  • Ability to provide informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cantonal Hospital of Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Thomas Gaisl, MD MPH PhD

CONTACT

+41762318339thomas.gaisl@uzh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 30, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)