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

NCT ID: NCT05445635

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-08-26

Brief Summary

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.

Conditions

Pulmonary Nodule, Solitary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Iriscope

Group Type: EXPERIMENTAL

Iriscope

Intervention Type: DEVICE

The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules

EBUS

Group Type: ACTIVE_COMPARATOR

Iriscope

Intervention Type: DEVICE

The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules

Combined Iriscope + EBUS

Group Type: EXPERIMENTAL

Iriscope

Intervention Type: DEVICE

The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules

Interventions

Iriscope

The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Olivier Taton

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olivier Taton, Resident

Role: PRINCIPAL_INVESTIGATOR

Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Locations

Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

P2021/770

Identifier Type: -

Identifier Source: org_study_id