Clinical trial · Interventional
Benefit of Cone-beam CT and Robotic-Assisted Bronchoscopy During Bronchoscopy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnosis | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Assisted Bronchoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- 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.
- type
- ACTIVE_COMPARATOR
- label
- Cone-beam CT and robotic assisted bronchoscopy
- description
- 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.
- interventionNames
- Diagnostic Test: Robotic Assisted Bronchoscopy
Primary outcomes (1)
- measure
- Diagnostic Yield
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (0)
Data not yet available