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

Primary Purpose

Pulmonary Nodule, Solitary

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Iriscope

About this trial

This is an interventional diagnostic trial for Pulmonary Nodule, Solitary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Erasme HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Iriscope

EBUS

Combined Iriscope + EBUS

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications of bronchoscopy

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

Full Information

NCT ID

NCT05445635

First Posted

June 27, 2022

Last Updated

September 5, 2023

Sponsor

Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05445635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Nodule, Solitary

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iriscope

Arm Type

Experimental

Arm Title

EBUS

Arm Type

Active Comparator

Arm Title

Combined Iriscope + EBUS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Iriscope

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic yield of bronchoscopy

Description

Time Frame

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 Measure Information:

Title

Complications of bronchoscopy

Description

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

Time Frame

Just after the bronchoscopy to 1 month after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olivier Taton, Resident

Phone

025553943

olivier.taton@erasme.ulb.ac.be

First Name & Middle Initial & Last Name or Official Title & Degree

Dimitri Leduc, Professor

Phone

025553943

dimitri.leduc@erasme.ulb.ac.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Taton, Resident

Organizational Affiliation

Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erasme Hospital

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier Taton, Resident

Phone

025553943

olivier.taton@erasme.ulb.ac.be

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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