Robot-Guided lung biopsy aims for bullseye accuracy

NCT ID NCT06084208

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study is testing whether a robotic system called ION, combined with real-time 3D CT imaging, can more accurately biopsy lung nodules. About 132 adults with small to medium-sized lung nodules will undergo the procedure under general anesthesia. The goal is to see how often the robot successfully reaches and samples the nodule, and to track safety and the learning curve for doctors.

What this could mean

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

Active substance
Robotic navigational bronchoscopy system with cone beam CT imaging
What this could lead to
If successful, this could make lung nodule biopsies more accurate and safer, helping doctors diagnose lung cancer earlier.
What could go wrong
This is an early-stage device study with no control group, so results may not prove it's better than standard methods. The procedure still carries risks like bleeding or 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

132 people

The number who actually took part.

Started

Sep 2023

Finished

Feb 2026

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. Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per Investigator's discretion. 3. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largest dimension (based on pre-procedure CT scan). 4. Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan. 5. Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention. 6. Patient is willing and able to give written informed consent for Clinical Investigation participation. 7. Patient is not legally incapacitated or in a legal/court ordered institution. Exclusion Criteria: 1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure. 2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure. 3. Presence of bullae(s) with a size of \>1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments. 4. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan. 5. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. 6. Patient underwent a pneumonectomy. 7. Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state. 8. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. 9. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. 10. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 11. Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation. 12. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation. 13. Patient is not willing to comply with post study procedure participation requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Radboud University Medical Center

    Nijmegen, 6500 HB, Netherlands

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