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
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