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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Nodule, Solitary
• Intervention / Treatment: Device: Iriscope

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier Taton, Resident; Phone Number: 025553943; Email: olivier.taton@erasme.ulb.ac.be
• Study Contact Backup: Name: Dimitri Leduc, Professor; Phone Number: 025553943; Email: dimitri.leduc@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme hospital
    • Contact: Olivier Taton, Resident; Phone Number: 025553943; Email: olivier.taton@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Olivier Taton, Resident, Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: P2021/770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No