Lung LesionsRobofolNCT07006311
Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol
A study testing Robotic-assisted bronchoscopy under propofol in people with Lung Lesions and Robotic Assisted Bronchoscopy, run by University of Zurich at 1 site in Switzerland.
Trial summary
In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Lesions, Robotic Assisted Bronchoscopy, Propofol
- What is being tested?
- Robotic-assisted bronchoscopy under propofol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Aug 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- informed consent signed by the subject
- aged at least 18 years
- scheduled for bronchoscopy with moderate sedation and tracheal intubation in order to obtain at least 1 specimens of the lung via transbronchial biopsy
- necessary periinterventional laboratory examinations needed for the bronchoscopy
- judgement of the subject
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol: A Single-center Pilot Study.
In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.
- Being tested
- Robotic-assisted bronchoscopy under propofol
- Keywords
- Robotic-assisted bronchoscopy, robotic assisted bronchoscopy, diagnosis of lung lesions, moderate sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted bronchoscopy under propofolDevice
In this study, patients will undergo a robotic-assisted bronchoscopy under moderate sedation with propofol. While the use of propofol as a sedative is common for manual bronchoscopies, robotic-assisted bronchoscopy is only permitted under general anesthesia. In the study intervention, the investigators want to test the feasibility of the combination of robotic-assisted bronchoscopy under propofol.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted bronchoscopy with Propofol | Experimental | Not described Receives: Device: Robotic-assisted bronchoscopy under propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of tool-in-lesion
Composite outcome defined as meeting at least one of the following criteria: 1) Radiological confirmation of the biopsy tool located within the target lung lesion using cone-beam CT. 2) Positive signal on radial endobronchial ultrasound (rEBUS) indicating the lesion was reached. 3) Pathological confirmation of specific malignant or benign tissue in the biopsy sample.
Measured: during the intervention
Acquisition of at least one histological sample
Measured: during the intervention
histopathological classification of the pulmonary lesion
Measured: From enrollment to the end of treatment at 8 days.
Secondary outcomes (5)
Procedure duration
Measured: during the intervention
Diagnostic yield of biopsies
According to the ATS2024 strict consensus criteria (https://doi.org/10.1164/rccm.202401-0192ST)
Measured: From enrollment to the end of treatment at 8 days.
diagnostic accuracy for malignancy
Biopsies with definitive malignancy/Cases with proven malignance over the course of 3 months
Measured: From enrollment to the end of treatment of 3 months
cost analysis
Total billed costs in CHF for the bronchoscopy excl. anesthesia
Measured: From enrollment to the end of treatment at 8 days.
Safety profile
Rate of pneumothoraces, bleeding rates (Nashville Classification Grad >2), and rate of unplanned hospitalizations >5 days.
Measured: From enrollment to the end of treatment at 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start14 Aug 2025
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Why it stopped: After enrolment of 10 patients, key study personnel left the institution, making continuation of the study at the current site no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung LesionsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006311
- Sponsor's protocol ID
- BASEC-Nr: 2025-D0013
- Acronym
- Robofol
- Status last verified
- Jul 2026
- First submitted
- 14 May 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol: A Single-center Pilot Study.
- ClinicalTrials.gov ID
- NCT07006311
- Acronym / sponsor ID
- Robofol / BASEC-Nr: 2025-D0013
- Keywords
- Robotic-assisted bronchoscopy, robotic assisted bronchoscopy, diagnosis of lung lesions, moderate sedation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After enrolment of 10 patients, key study personnel left the institution, making continuation of the study at the current site no longer feasible.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 5 Jun 2025 (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.
In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted bronchoscopy with Propofol | Experimental | Device: Robotic-assisted bronchoscopy under propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent signed by the subject
- aged at least 18 years
- scheduled for bronchoscopy with moderate sedation and tracheal intubation in order to obtain at least 1 specimens of the lung via transbronchial biopsy
- necessary periinterventional laboratory examinations needed for the bronchoscopy
- judgement of the subject
Key exclusion criteria (3 listed)
- 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 bronchoscopy under propofolIn this study, patients will undergo a robotic-assisted bronchoscopy under moderate sedation with propofol. While the use of propofol as a sedative is common for manual bronchoscopies, robotic-assisted bronchoscopy is only permitted under general anesthesia. In the study intervention, the investigators want to test the feasibility of the combination of robotic-assisted bronchoscopy under propofol. | Device | Robotic-assisted bronchoscopy with Propofol |
Primary outcome
Confirmation of tool-in-lesion
Time frame: during the intervention
Composite outcome defined as meeting at least one of the following criteria: 1) Radiological confirmation of the biopsy tool located within the target lung lesion using cone-beam CT. 2) Positive signal on radial endobronchial ultrasound (rEBUS) indicating the lesion was reached. 3) Pathological confirmation of specific malignant or benign tissue in the biopsy sample.
Acquisition of at least one histological sample
Time frame: during the intervention
histopathological classification of the pulmonary lesion
Time frame: From enrollment to the end of treatment at 8 days.
5 secondary outcomes
Procedure duration
Time frame: during the intervention
Diagnostic yield of biopsies
Time frame: From enrollment to the end of treatment at 8 days.
diagnostic accuracy for malignancy
Time frame: From enrollment to the end of treatment of 3 months
cost analysis
Time frame: From enrollment to the end of treatment at 8 days.
Safety profile
Time frame: From enrollment to the end of treatment at 8 days.
Results and safety
The study was stopped early (reason given: After enrolment of 10 patients, key study personnel left the institution, making continuation of the study at the current site no longer feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 under propofol in people with Lung Lesions and Robotic Assisted Bronchoscopy, 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Jul 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?
The study was stopped early (reason given: After enrolment of 10 patients, key study personnel left the institution, making continuation of the study at the current site no longer feasible.). Results are not available in the source record.
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?
Confirmation of tool-in-lesion (time frame: during the intervention). The study lists 3 primary outcomes in all. 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 24 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.