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

• Sponsor: Erasme University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05445635
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Nodule, Solitary	Device: Iriscope	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses
• Actual Study Start Date: Jun 2, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Diagnostic yield of bronchoscopy [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.]

   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.

Secondary Outcome Measures

1. Complications of bronchoscopy [Just after the bronchoscopy to 1 month after the procedure]

   Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme Hospital	Brussels		Belgium	1070

Sponsors and Collaborators

• Erasme University Hospital

Investigators

• Principal Investigator: Olivier Taton, Resident, Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olivier Taton, Doctor, Erasme University Hospital
• ClinicalTrials.gov Identifier: NCT05445635
• Other Study ID Numbers: P2021/770
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule

Study Results

No Results Posted as of Jul 6, 2022