An interventional study of Iriscope in Pulmonary Nodule, Solitary, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Erasme University Hospital · Not applicable, Interventional, and Diagnostic
Since the beginning of lung screening program in the different countries around the world by chest CT scan, numerous lung nodules and masses of unknown etiology are diagnosed.
Usually, the pathological diagnosis is obtained by bronchoscopy. However, peripheral bronchi cannot be seen after the fifth bronchial division as the diameter of the broncoscope is greated than the diameter of the bronchi. Therefore, the Iriscope was developed. It consists in a thin catheter with a mini-camera at its distal extremity.
The aime of this study is to evaluate the diagnostic yield of bronchoscopy guided by Iriscope in the setting of peripheral lung nodules and masses supect of malignancy, to compare the Iriscope to endobronchial radial ultrasonography (which is a validated technique to guide bronchoscopy in the setting of peripheral lung nodules and masses) and to evaluate the added value on the diagnostic yield by combining these 2 techniques.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's enrollment of 91 is close to the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Device: Iriscope
Device: Iriscope
Device: Iriscope
The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules
Diagnostic yield of bronchoscopy
The diagnosis will be obtained by pathological analysis. The diagnostic yield is the number of cases with a pathological diagnosis obtained by bronchoscopy on the total number of cases. In case of unspecified diagnosis, the fianal diagnosis will be given by the pathological naalysis of the surgical resection or chest CT follow up.
Time frame: Pathological diagnosis just after the bronchoscopy. In case of unspecified diagnosis after bronchoscopy, a follow up may be performed by chest ct scan up to 6 months.
Complications of bronchoscopy
Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy
Time frame: Just after the bronchoscopy to 1 month after the procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital