Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol

NCT07006311 | Recruiting DMC FDA Device

• 1 other identifier: BASEC-Nr: 2025-D0013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.

Conditions

Lung Lesions; Robotic Assisted Bronchoscopy; Propofol; Bronchoscopy; Bronchoscopy Biopsy

Keywords

Robotic-assisted bronchoscopy; robotic assisted bronchoscopy; diagnosis of lung lesions; moderate sedation

Outcome Measures

Primary Outcomes (3)

• 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.

  during the intervention

• Acquisition of at least one histological sample

  during the intervention

• histopathological classification of the pulmonary lesion

  From enrollment to the end of treatment at 8 days.

Secondary Outcomes (5)

• Procedure duration

  during the intervention

• Diagnostic yield of biopsies

  From enrollment to the end of treatment at 8 days.

• diagnostic accuracy for malignancy

  From enrollment to the end of treatment of 3 months

• cost analysis

  From enrollment to the end of treatment at 8 days.

• Safety profile

  From enrollment to the end of treatment at 8 days.

Study Arms (1)

Robotic-assisted bronchoscopy with Propofol

EXPERIMENTAL

Device: Robotic-assisted bronchoscopy under propofol

Interventions

Robotic-assisted bronchoscopy under propofol DEVICE

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.

Robotic-assisted bronchoscopy with Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

CH (1)