Lung NeoplasmsNCT06489678
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
A study testing Robotic Assisted Bronchoscopy in people with Lung Neoplasms and Diagnosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Diagnosis, Lung Cancer
- What is being tested?
- Robotic Assisted Bronchoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jun 2024to 30 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18 years
- Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
- Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
- Informed consent
Who cannot join
- Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
- Previous randomization to an arm of the present trial
- Endobronchial lesion causing lobar atelectasis
- Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
- Pregnant or lactating women
- For nested RCTs (Trial A + B):
- A: At least 1 peripheral lung lesion suspicious for lung cancer, beyond the visual range of the bronchoscope, rounded or irregular opacity, may be well or poorly defined, measuring ≤3 cm in diameter of the short axis (in CT scan)
- B:At least 1 peripheral target lung lesion of any kind beyond the visual range of the bronchoscope (measuring >3 cm in diameter of the short axis and/or with an interstitial pattern)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: The Benefit of Cone-beam Computed Tomography and Robotic Assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Lesions and Other Lung Disease Requiring Lung Biopsy: An Open-label, Randomized, Controlled Trial.
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.
Read the detailed description
This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound.
The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB .
Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.
- Conditions
- Lung Neoplasms, Diagnosis, Lung Cancer
- Being tested
- Robotic Assisted Bronchoscopy
- Keywords
- Cone-beam CT, Robotic assisted Bronchoscopy, Cios Spin, Ion endoluminal System, Advanced Bronchoscopy
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted BronchoscopyDiagnostic test
Also called Cios Spin (Siemens) and Ion endoluminal system (Intuitive)
Cone-beam computed tomography (CBCT) technology and robotic-assisted bronchoscopy (RAB) present promising methods to enhance biopsy accuracy and procedural safety through 3-dimensional reconstructions and increased bronchoscope tip flexibility. Additionally, the transfer of navigational data between CBCT and RAB may further improve diagnostic yield. Given their distinct approaches to enhancing diagnostic outcomes, two separate study arms are warranted for CBCT and RAB.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | For the control arm, standard bronchoscopy (±virtual or electromagnetic navigation, r-EBUS, and 2-dimensional fluoroscopy) will be employed, using various types of bronchoscopes (±ultra-thin bronchoscopes) and biopsy tools (needle, cryoprobe, forceps) at the investigator's discretion. |
| Cone-beam CT and robotic assisted bronchoscopy | Active comparator | Usual care with Cone-beam CT and the added option for the use of robotic assisted bronchoscopy (Ion endoluminal System, Intuitive) during the procedure. A connection between the cone-beam CT and the robotic system (NaviLink) is also possible. Receives: Diagnostic Test: Robotic Assisted Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield
ATS 2024 consensus criteria
Measured: Including a 12-month follow-up (clinical data)
Secondary outcomes (5)
Radiation exposure
Dose area product
Measured: During Intervention
Safety profile
Rates of complications (bleeding, pneumothorax, pneumonia)
Measured: During Intervention
Diagnostic accuracy for milignancy
True positives + true negatives / true positives + true negatives + false positives + false negatives
Measured: Including a 12-month follow-up (clinical data)
Quality of biopsies
Number of malignant cells, suitability rates for further molecular pathological testing
Measured: During Intervention
Navigation success
Anatomical confirmation of the position of the catheter in front or within the lesion as confirmed by r-EBUS or CBCT [not fluoroscopy]
Measured: During Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start25 Jun 2024
- Primary completion1 Oct 2025
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Gaisl, University of Zurich
- Investigators
- Thomas Gaisl, MD MPH PhD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489678
- Sponsor's protocol ID
- BASEC Nr. 2024-00684
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Cone-beam Computed Tomography and Robotic Assisted Bronchoscopy for the Diagnosis of Peripheral Pulmonary Lesions and Other Lung Disease Requiring Lung Biopsy: An Open-label, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06489678
- Acronym / sponsor ID
- BASEC Nr. 2024-00684
- Conditions
- Lung Neoplasms, Diagnosis, Lung Cancer
- Keywords
- Cone-beam CT, Robotic assisted Bronchoscopy, Cios Spin, Ion endoluminal System, Advanced Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 8 Jul 2024 (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.
This randomized controlled trial evaluates the integration of cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) for diagnosing pulmonary lesions, hypothesizing improved diagnostic yield compared to traditional methods. The trial involves 2 study arms (2x46 lesions) over 24 months with 12 months of follow-up and the diagnostic yield (ATS 2024 criteria) as the primary endpoint.
Detailed description
This randomized-controlled-trial, classified as Category A under Art 6 ClinO-MD, investigates the potential benefits of integrating cone-beam computed tomography (CBCT) and robotic-assisted bronchoscopy (RAB) into clinical practice for diagnosing pulmonary lesions. The study aims to enhance biopsy accuracy and safety by utilizing 3-dimensional reconstructions and increased flexibility of the bronchoscope tip. It targets two main clinical scenarios: peripheral lung lesions (PPLs) and other lung diseases requiring tissue biopsies. The hypothesis is that CBCT and RAB will significantly improve diagnostic yield compared to traditional 2D fluoroscopy techniques and endobronchial ultrasound.
The trial will involve 300 participants in the overall observational study, with a nested randomized controlled trial (RCT) for specific lesion types, targeting 2x46 lesions for 2 study arms i) usual care, ii) CBCT and RAB .
Primary endpoints include procedure time for the overall trial and diagnostic yield (ATS 2024 criteria) for the nested RCTs, analyzed via Pearson's Chi-squared test and multivariable logistic regression. Inclusion criteria encompass patients aged 18 or older, scheduled for bronchoscopy, with necessary pre-interventional exams and informed consent. Exclusion criteria include inability to tolerate the procedure, pregnancy, previous trial randomization, and specific lung conditions. The study's recruitment phase spans 24 months, with a 12-month follow-up, running from July 2024 to July 2027.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –For the control arm, standard bronchoscopy (±virtual or electromagnetic navigation, r-EBUS, and 2-dimensional fluoroscopy) will be employed, using various types of bronchoscopes (±ultra-thin bronchoscopes) and biopsy tools (needle, cryoprobe, forceps) at the investigator's discretion. |
| Cone-beam CT and robotic assisted bronchoscopy | Active comparator | Diagnostic Test: Robotic Assisted BronchoscopyUsual care with Cone-beam CT and the added option for the use of robotic assisted bronchoscopy (Ion endoluminal System, Intuitive) during the procedure. A connection between the cone-beam CT and the robotic system (NaviLink) is also possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged >18 years
- Scheduled for bronchoscopy in order to obtain at least 1 specimen(s) of the lung via transbronchial biopsy
- Necessary periinterventional laboratory examinations and other examinations needed for the bronchoscopy
- Informed consent
Key exclusion criteria (8 listed)
- Not able to tolerate procedure (bronchoscopy or apnea for CBCT)
- Previous randomization to an arm of the present trial
- Endobronchial lesion causing lobar atelectasis
- Inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders, or severe neurosis)
- Pregnant or lactating women
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 BronchoscopyAlso: Cios Spin (Siemens) and Ion endoluminal system (Intuitive)Cone-beam computed tomography (CBCT) technology and robotic-assisted bronchoscopy (RAB) present promising methods to enhance biopsy accuracy and procedural safety through 3-dimensional reconstructions and increased bronchoscope tip flexibility. Additionally, the transfer of navigational data between CBCT and RAB may further improve diagnostic yield. Given their distinct approaches to enhancing diagnostic outcomes, two separate study arms are warranted for CBCT and RAB. | Diagnostic test | Cone-beam CT and robotic assisted bronchoscopy |
Primary outcome
Diagnostic Yield
Time frame: Including a 12-month follow-up (clinical data)
ATS 2024 consensus criteria
5 secondary outcomes
Radiation exposure
Time frame: During Intervention
Safety profile
Time frame: During Intervention
Diagnostic accuracy for milignancy
Time frame: Including a 12-month follow-up (clinical data)
Quality of biopsies
Time frame: During Intervention
Navigation success
Time frame: During Intervention
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 5 May 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. This study is not recruiting at the moment.
Thomas Gaisl, MD MPH PhD study director
University of Zurich
1 site 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 in people with Lung Neoplasms and Diagnosis, run by University of Zurich at 1 site 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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Yield (time frame: Including a 12-month follow-up (clinical data)). 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 5 May 2026.