Robot-Assisted lung biopsy shows promise in accuracy study
NCT ID NCT05867953
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a robotic system (Ion Endoluminal System) to see how accurately it can place a biopsy tool into lung nodules. 200 adults with lung nodules between 6 mm and 3 cm took part. The system uses real-time 3D imaging to guide the biopsy needle. The main goal was to measure how often the tool reached the nodule directly before sampling.
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 real-time 3D imaging
- What this could lead to
- If successful, this could improve the accuracy of lung biopsies, leading to better diagnosis of lung cancer with fewer complications.
- What could go wrong
- This is a completed device study, not a treatment trial. It only measures tool placement accuracy, not patient outcomes. Results may not change standard care.
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
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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
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200 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jun 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan. 4. Patient with American Society of Anesthesiologists Classification (ASA) ≥4. 5. Patient underwent a pneumonectomy. 6. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state. 7. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. 8. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. 9. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. 10. 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. 11. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation. 12. 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
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Barts Health Nhs Trust
London, E1 1FR, United Kingdom
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Royal Brompton & Harefield Hospitals, Part of Guy'S and St Thomas' Nhs Foundation Trust
London, SW3 6NP, United Kingdom
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