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Which lung biopsy method is safer and more accurate?

NCT ID NCT07761351

Diagnosis Sponsor: Intuitive Surgical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This trial compares two established biopsy methods for small lung nodules (≤2 cm): CT-guided percutaneous biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT. The goal is to see which approach is more effective at diagnosing cancer and which has fewer complications, such as pneumothorax (collapsed lung). Adults with a lung nodule needing biopsy may participate. The study will measure diagnostic accuracy and safety to help guide future clinical decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two biopsy procedures: shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT) and CT-guided percutaneous lung nodule biopsy
What this could lead to
If successful, this could help doctors choose the best biopsy method for small lung nodules, improving diagnostic accuracy and reducing complications like collapsed lungs.
What could go wrong
The trial is in phase 4 and involves 550 participants, but results may not apply to all patients or nodules. Both procedures carry risks, including bleeding or pneumothorax (collapsed lung).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is aged 18 years or older at time of consent. 2. Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent). 3. Target pulmonary nodule ≤2 cm in largest diameter. 4. Patient is willing and able to give written informed consent for clinical study participation. Exclusion Criteria: 1. Patient has previously undergone a biopsy procedure of the target nodule by any approach. 2. Patient was previously randomized in this study but did not undergo biopsy. 3. Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results. 4. Patient is pregnant or breastfeeding as determined by standard site practices. 5. Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor. 6. Patient is not willing to comply with study participation requirements.

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Conditions

The condition(s) this trial relates to.

disease lung cancer lung neoplasm Multiple Pulmonary Nodules

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer (diagnosis) Lung nodule

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Basel University Hospital

    RECRUITING

    Basel, Canton of Basel-City, 4031, Switzerland

  • University College London Hospitals NHS Foundation

    RECRUITING

    London, NW1 2PG, United Kingdom

More trials for these conditions

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