RecruitingOBSERVATIONAL

European Real-World Registry for Use of the Ion Endoluminal System

This study is gathering information about a medical device called the Ion Endoluminal System. This system helps doctors perform biopsies (taking a small tissue sample) or locate growths (nodules) in the lungs. It's for people who might have lung cancer or other lung conditions. We want to see how well it works and what happens to patients who use it in everyday medical care. This isn't testing a new drug, but rather observing how an approved device performs. The goal is to collect information from about 1,200 patients to understand both the short-term and long-term results of using this system.

At a glance

Status

Recruiting

Sponsor

Intuitive Surgical

Enrolment target

1,200

Start

09 Sep 2025

Estimated completion

01 Oct 2029

Pulmonary Nodule Lung Cancer

What is this study about?

Imagine your doctor finds a small spot or growth in your lung. They might need to take a tiny sample (called a biopsy) to find out what it is, or they might need help finding its exact location to plan treatment. This study is about a special tool called the Ion Endoluminal System that helps doctors do these things.

We're collecting information from patients like you who are already having a procedure using this system. It's not a trial where you get a new treatment; instead, we're watching how the system is used in normal doctor's visits and how patients get on afterwards. We want to understand how effective and safe it is when used in the real world.

By gathering information from many patients, we hope to learn more about how this system helps doctors and patients in diagnosing and managing lung conditions. This information can help improve care for future patients.

Key takeaways

This study observes an approved medical device for lung procedures.
It collects real-world information on how the Ion Endoluminal System works.
Participation involves routine follow-up after your planned procedure.
Results help improve care for future patients needing lung biopsies or localization.
Your medical treatment will not change because of joining this study.
You can withdraw from the study at any point without affecting your care.

Who may be eligible?

To join this study, you must be at least 18 years old. Your doctor must be planning to use the Ion Endoluminal System for a lung biopsy or to help find a growth in your lung. You also need to be willing to understand and sign a consent form, and agree to follow the study's instructions after your procedure.

There are some reasons you can't join. For example, if you're already in another study that involves new medicines or treatments with unknown risks. Also, if you are pregnant or breastfeeding, you won't be able to take part. Being legally unable to make decisions for yourself, or being dependent on the study staff, would also prevent you from joining. Finally, if the doctor believes it's not in your best interest to be in the study, you won't be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Is your doctor planning to use the Ion Endoluminal System for your lung procedure?
Are you able and willing to sign a consent form?
Are you able to attend any necessary follow-up appointments?
Are you not currently pregnant or breastfeeding?
Are you not in another research study involving new or untested medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be observed during and after your procedure where the Ion Endoluminal System is used. You won't be given any experimental medicines; the system is already approved for use. The study will mainly involve collecting information about your procedure and your health afterwards. This might mean attending follow-up appointments as you normally would, where doctors will record how you're doing. The study aims to gather information on your health both in the short and long term, following your procedure. We will collect information until about 1,200 patients have had their procedure using this system.

Potential risks and benefits

There are no new experimental treatments in this study, so the risks are generally those associated with the lung biopsy or localization procedure itself, which your doctor will discuss with you. Taking part helps researchers understand how devices perform in real-world settings, which can benefit future patients. You are always free to change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hôpital Marie Lannelongue
Verified postcode
Le Plessis-Robinson, France· Recruiting
Helios Klinikum Emil von Behring
Verified postcode
Berlin, Germany· Not yet recruiting
Universitätsspital Zürich
Verified postcode
Zurich, Switzerland· Recruiting
University College London Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is the Ion Endoluminal System?

It's a special medical tool used by doctors to help take samples from lung growths or pinpoint their exact location.

Am I receiving a new treatment?

No, this study is about observing how an already approved medical device works in real patients, not testing a new one.

What kind of information will be collected?

Doctors will record details about your procedure and how you recover afterwards, both in the short and long term.

How long will I be followed in the study?

The study aims to observe your health for both short-term and long-term effects after your procedure. The total study duration isn't fixed for each person, but depends on the overall patient recruitment.

Can I leave the study at any time?

Yes, you can choose to leave the study whenever you want, and your medical care will not be affected.

How to find out more

Jana Meschede

ioneuregistry@intusurg.com +41 21 821 2000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.