Robot-Guided lung biopsy aims for bullseye accuracy
NCT ID NCT06084208
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lung cancer are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A spoonful of olive oil before lung surgery: a new shield against a rare complication?
- Mobile lung cancer clinics aim to close rural screening gap
- Can protein patterns in stored tumors point to new treatment targets?
- Lung surgery without a breathing tube: a gentler path to recovery?
- A single blood draw to detect five cancers before symptoms appear?
- A breath sniff could one day screen for lung cancer and more