Pulmonary Nodule, SolitaryNCT05445635
Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses
A study testing Iriscope in people with Pulmonary Nodule, Solitary, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- Iriscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jun 2022to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters
Who cannot join
- Any contraindication to general anesthesia
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Iriscope
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IriscopeDevice
The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules
| Study group | Role | What they receive |
|---|---|---|
| Iriscope | Experimental | Not described Receives: Device: Iriscope |
| EBUS | Active comparator | Not described Receives: Device: Iriscope |
| Combined Iriscope + EBUS | Experimental | Not described Receives: Device: Iriscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy
Measured: Just after the bronchoscopy to 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start2 Jun 2022
- Primary completion30 Jun 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Taton, Erasme University Hospital
- Investigators
- Olivier Taton, Resident, Principal investigator, Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445635
- Sponsor's protocol ID
- P2021/770
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of a Small Camera (Iriscope) in the Endoscopic Diagnosis of Peripheral Lung Nodules and Masses
- ClinicalTrials.gov ID
- NCT05445635
- Acronym / sponsor ID
- P2021/770
- Conditions
- Pulmonary Nodule, Solitary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iriscope | Experimental | Device: Iriscope |
| EBUS | Active comparator | Device: Iriscope |
| Combined Iriscope + EBUS | Experimental | Device: Iriscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters
Key exclusion criteria (2 listed)
- Any contraindication to general anesthesia
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IriscopeThe use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules | Device | Combined Iriscope + EBUS, EBUS, Iriscope |
Primary outcome
Diagnostic yield of bronchoscopy
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.
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.
1 secondary outcome
Complications of bronchoscopy
Time frame: Just after the bronchoscopy to 1 month after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Taton, Resident principal investigator
Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iriscope in people with Pulmonary Nodule, Solitary, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of bronchoscopy (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.