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

Free University of Brussels (ULB)

Status: Completed

Conditions: Pulmonary Nodule, Solitary

Treatments: Device: Iriscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05445635

P2021/770

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

Iriscope

Experimental group

Treatment:

Device: Iriscope

EBUS

Active Comparator group

Treatment:

Device: Iriscope

Combined Iriscope + EBUS

Experimental group

Treatment:

Device: Iriscope