Interstitial Lung Disease (ILD)RAB-ILD-RCTNCT07500818
Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease
A study testing Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance and Conventional Bronchoscopy With Fluoroscopy Guidance in people with Interstitial Lung Disease (ILD) and Lung Biopsy, run by University of Zurich at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Disease (ILD), Lung Biopsy
- What is being tested?
- Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance and Conventional Bronchoscopy With Fluoroscopy Guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Feb 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Definite UIP pattern on HRCT
- Severe pulmonary hypertension
- Severe hypoxemia contraindicating bronchoscopy
- Coagulopathy or contraindication to biopsy
- Pregnancy
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Cantonal Hospital of Lucerne
Lucerne, Canton of Lucerne, 6000
Fiorenza Gautschi, MD, +41 205 22 82, fiorenza.gautschi@luks.ch
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Carolin Steinack, MD, +41442553828, carolin.steinack@usz.ch
About this study
Official title: Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Histopathologic evaluation remains a key component in the diagnosis of many interstitial lung diseases when radiological and clinical findings are inconclusive. Transbronchial lung cryobiopsy (TBLC) has increasingly replaced surgical lung biopsy due to its lower morbidity, but diagnostic yield varies widely depending on procedural technique and sampling accuracy.
Robotic-assisted bronchoscopy (RAB) offers improved catheter stability and precise navigation to peripheral lung regions. When combined with cone-beam CT (CBCT), RAB allows real-time confirmation of biopsy location, potentially improving sampling of diagnostically relevant lung parenchyma while avoiding bronchial structures.
However, the incremental diagnostic value of RAB combined with CBCT compared with conventional bronchoscopy using fluoroscopy guidance has not yet been evaluated in a randomized controlled trial.
This investigator-initiated trial aims to determine whether robotic-assisted bronchoscopy with CBCT improves the rate of definitive histological diagnosis compared with conventional bronchoscopy.
Participants will be randomized 1:1 to either:
- Conventional bronchoscopy with fluoroscopy-guided cryobiopsy
- Robotic-assisted bronchoscopy with CBCT-guided cryobiopsy
In both arms, four biopsies will be obtained from two different lung lobes using a 1.7 mm cryoprobe.
Histological specimens will be evaluated by a blinded multidisciplinary ILD board.
- Conditions
- Interstitial Lung Disease (ILD), Lung Biopsy
- Being tested
- Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance, Conventional Bronchoscopy With Fluoroscopy Guidance
- Keywords
- Robotic-assisted Bronchoscopy, Cryobiopsy, CBCT, Interventional Pulmonology, Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Bronchoscopy With Cone-Beam CT GuidanceProcedure or surgery
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.
Conventional Bronchoscopy With Fluoroscopy GuidanceProcedure or surgery
Flexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Bronchoscopy With Fluoroscopy Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Diagnosis
Rate of Definitive Histological Diagnosis
Measured: Perioperative/Periprocedural
Secondary outcomes (3)
Biopsy Size
Mean cross-sectional area of cryobiopsy specimens measured in mm².
Measured: Perioperative/Periprocedural
Tissue Composition of Biopsies
Percentage composition of biopsy specimens including:
- Lung parenchyma
- Bronchial tissue
- Bronchiolar tissue
Measured: Perioperative/Periprocedural
Safety Composite
Composite safety endpoint including:
- Clinically significant bleeding
- Pneumothorax requiring intervention
- Transfer to intensive care unit
Measured: Up to 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of Lucerne, Switzerland, University Hospital, Zürich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500818
- Sponsor's protocol ID
- BASEC Nr. 2024-00684 Trial B
- Acronym
- RAB-ILD-RCT
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07500818
- Acronym / sponsor ID
- RAB-ILD-RCT / BASEC Nr. 2024-00684 Trial B
- Conditions
- Interstitial Lung Disease (ILD), Lung Biopsy
- Keywords
- Robotic-assisted Bronchoscopy, Cryobiopsy, CBCT, Interventional Pulmonology, Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Cantonal Hospital of Lucerne, Switzerland, University Hospital, Zürich
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Histopathologic evaluation remains a key component in the diagnosis of many interstitial lung diseases when radiological and clinical findings are inconclusive. Transbronchial lung cryobiopsy (TBLC) has increasingly replaced surgical lung biopsy due to its lower morbidity, but diagnostic yield varies widely depending on procedural technique and sampling accuracy.
Robotic-assisted bronchoscopy (RAB) offers improved catheter stability and precise navigation to peripheral lung regions. When combined with cone-beam CT (CBCT), RAB allows real-time confirmation of biopsy location, potentially improving sampling of diagnostically relevant lung parenchyma while avoiding bronchial structures.
However, the incremental diagnostic value of RAB combined with CBCT compared with conventional bronchoscopy using fluoroscopy guidance has not yet been evaluated in a randomized controlled trial.
This investigator-initiated trial aims to determine whether robotic-assisted bronchoscopy with CBCT improves the rate of definitive histological diagnosis compared with conventional bronchoscopy.
Participants will be randomized 1:1 to either:
- Conventional bronchoscopy with fluoroscopy-guided cryobiopsy
- Robotic-assisted bronchoscopy with CBCT-guided cryobiopsy
In both arms, four biopsies will be obtained from two different lung lobes using a 1.7 mm cryoprobe.
Histological specimens will be evaluated by a blinded multidisciplinary ILD board.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance | Experimental | Procedure: Robotic-Assisted Bronchoscopy With Cone-Beam CT GuidanceRobotic-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. |
| Conventional Bronchoscopy With Fluoroscopy Guidance | Active comparator | Procedure: Conventional Bronchoscopy With Fluoroscopy GuidanceFlexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Definite UIP pattern on HRCT
- Severe pulmonary hypertension
- Severe hypoxemia contraindicating bronchoscopy
- Coagulopathy or contraindication to biopsy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-Assisted Bronchoscopy With Cone-Beam CT GuidanceRobotic-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 or surgery | Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance |
| Conventional Bronchoscopy With Fluoroscopy GuidanceFlexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe. | Procedure or surgery | Conventional Bronchoscopy With Fluoroscopy Guidance |
Primary outcome
Histological Diagnosis
Time frame: Perioperative/Periprocedural
Rate of Definitive Histological Diagnosis
3 secondary outcomes
Biopsy Size
Time frame: Perioperative/Periprocedural
Tissue Composition of Biopsies
Time frame: Perioperative/Periprocedural
Safety Composite
Time frame: Up to 24 hours post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance and Conventional Bronchoscopy With Fluoroscopy Guidance in people with Interstitial Lung Disease (ILD) and Lung Biopsy, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Gaisl, MD MPH PhD (+41762318339, thomas.gaisl@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Diagnosis (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.