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

NCT05445635 | Completed

• 1 other identifier: P2021/770
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications of bronchoscopy

  Just after the bronchoscopy to 1 month after the procedure

Study Arms (3)

Iriscope

EXPERIMENTAL

Device: Iriscope

EBUS

ACTIVE COMPARATOR

Device: Iriscope

Combined Iriscope + EBUS

EXPERIMENTAL

Device: Iriscope

Interventions

Iriscope DEVICE

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

Combined Iriscope + EBUS; EBUS; Iriscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters

You may not qualify if:

• Any contraindication to general anesthesia
• Coagulopathy

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Olivier Taton, Resident

  Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: June 2, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 26, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

BE (1)