RecruitingPHASE4INTERVENTIONAL

A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy

The ENCOMPASS study is looking at two standard ways doctors take a small sample (biopsy) from tiny spots in the lung, often to check for lung cancer. These spots are called lung nodules and are 2cm or smaller. The two methods being compared are a biopsy guided by a CT scan through the skin, and a robotic-assisted bronchoscope that uses special imaging. This study wants to see if the robotic method is just as good at finding a diagnosis and safer than the CT-guided method. Patients will be randomly assigned to one of the two biopsy types. This is a large study involving many hospitals, and it only uses methods already available in hospitals, not new experimental treatments.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Intuitive Surgical

Enrolment target

550

Start

28 Aug 2026

Estimated completion

30 Apr 2029

Lung Cancer (Diagnosis)Lung Nodule

What is this study about?

Imagine you have a small spot, sometimes called a 'nodule,' in your lung that your doctor wants to investigate. This study, called ENCOMPASS, is designed to compare two common methods doctors use to take a tiny sample (a biopsy) from these spots. This sample is then sent to a lab to find out what the spot is, for example, to check for lung cancer.

The two biopsy methods being compared are: 1) a 'CT-guided biopsy,' where the doctor uses CT scans to guide a needle through your skin to the spot, and 2) 'robotic-assisted bronchoscopy,' where a doctor uses a thin, flexible tube with a camera (a bronchoscope) that's guided by a robot and special imaging (like a 3D X-ray called cone-beam CT) through your airway to reach the spot. Both methods are already used in hospitals. The study wants to know if the robotic method is just as good at getting a clear diagnosis and if it might be safer, causing fewer problems, especially a collapsed lung (called a pneumothorax).

If you join the study, you'll be put into one of the two groups by chance, like flipping a coin. You'll receive one of the two standard biopsy procedures. You won't get any experimental treatments or devices. Doctors will follow up on your health for up to a year, mainly by checking your medical records and during your usual hospital visits. You might also be asked to fill out questionnaires about your quality of life.

Key takeaways

Compares two standard biopsy methods for small lung spots.
Aims to find which method is best for diagnosis and safety.
Patients are randomly assigned to one of two existing procedures.
No experimental treatments are used in this study.
Participation involves a biopsy, follow-up, and optional questionnaires.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Your doctors must have decided that you need a biopsy for a lung spot that is 2 centimetres or smaller in size. You must also be willing and able to understand and sign a consent form, showing you agree to take part.

There are some reasons you might not be able to join. For example, if you've already had a biopsy on the same lung spot, or if you're pregnant or breastfeeding. You also can't take part if you're already in another research study that uses experimental treatments or if you can't commit to the study's requirements.

Also, if you've been put forward for this study before but didn't have the biopsy for some reason, you wouldn't be able to join again. The study wants to make sure everyone who participates can make their own decision freely and safely.

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?
Has your doctor said you need a biopsy for a lung spot (nodule) that is 2cm or smaller?
Are you willing and able to give your informed consent?
Have you NOT had a biopsy on this specific lung spot before?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the ENCOMPASS study, you will first read and sign a consent form. Then, you will be randomly assigned to receive one of two standard biopsy procedures: either the CT-guided biopsy or the robotic-assisted bronchoscopy. This is done by chance, like drawing names from a hat.

The assigned biopsy will be carried out by your medical team as they normally would, using standard hospital procedures and equipment. You will not receive any new or experimental treatments. After your biopsy, you will have a chest X-ray, which is standard practice. The study team will then follow your progress for up to 12 months. This will mostly involve reviewing your existing medical records and your regular check-up appointments. You may also be asked to fill in some questionnaires about your quality of life and, if you agree, your work status at different times throughout the year. No extra hospital visits, special tests, or advanced scans will be done just for the study.

Potential risks and benefits

Participating in this study means you'll receive one of two established biopsy procedures to diagnose your lung spot. The potential benefit is helping doctors understand which biopsy method works best and is safest for patients, which could improve care for everyone in the future. As with any medical procedure, there are potential risks associated with both biopsy types, such as bleeding, infection, or a collapsed lung, though these will be managed by your medical team. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (2)

Basel University Hospital
Verified postcode
Basel, Switzerland· Recruiting
University College London Hospitals NHS Foundation
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a lung nodule?

A lung nodule is a small spot or growth in your lung. They are quite common and most are not cancerous, but doctors often need to investigate them to be sure.

What is a biopsy?

A biopsy is a procedure where doctors take a small sample of tissue from your body to examine it closely under a microscope, usually to diagnose a condition.

Will I get a new treatment?

No, this study only uses biopsy methods that are already standard and routinely available in hospitals. You will not receive any experimental treatments.

How long will I be involved in the study?

If you take part, your health will be followed for up to 12 months, mainly through your regular medical records and appointments.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and it will not affect your medical care or relationship with your doctors.

How to find out more

Carine Van den Abeele

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

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