Status:
ACTIVE_NOT_RECRUITING
Benefit of Cone-beam CT and Robotic-assisted Bronchoscopy During Bronchoscopy
Lead Sponsor:
University of Zurich
Conditions:
Lung Neoplasms
Diagnosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 diag...
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 bronchosco...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06489678
Start Date
June 25 2024
End Date
July 30 2027
Last Update
November 1 2024
Active Locations (1)
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1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091