Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses

Study Overview
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Brief Summary
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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.

Official Title
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Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses

Conditions
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Pulmonary Nodule, Solitary

Intervention / Treatment
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* Device: Iriscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters Exclusion Criteria: Any contraindication to general anesthesia Coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iriscope<br> | Device: Iriscope<br>* The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules<br>|
| Active Comparator: EBUS<br> | Device: Iriscope<br>* The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules<br>|
| Experimental: Combined Iriscope + EBUS<br> | Device: Iriscope<br>* The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of bronchoscopy | Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy | Just after the bronchoscopy to 1 month after the procedure |