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Robot vs. manual: which tool best spots lung cancer?
NCT ID NCT06308120
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares a robotic bronchoscopy system (Ion) to a manual one (superDimension) for diagnosing lung nodules. About 354 adults with suspicious lung nodules will be randomly assigned to one of the two devices. The main goal is to see which device yields a correct diagnosis more often, with fewer complications like collapsed lungs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ion Endoluminal System (robotic bronchoscopy device)
- What this could lead to
- If successful, this could show that robotic bronchoscopy is more accurate and safer for diagnosing lung nodules, potentially becoming a new standard of care.
- What could go wrong
- This is a device comparison trial, not a treatment study. Even if one device is better, it may not improve patient outcomes or survival. Results may not apply to all nodule types or hospitals.
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
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354 people
The number who actually took part.
- Started
-
Mar 2024
- Expected to finish
-
Sep 2027
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 to 80 years
- Sex
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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. Able to tolerate bronchoscopy; 2. ≥18 years and ≤ 80 years; 3. Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation\*; 4. The pulmonary nodules are solid or part-solid; 5. The maximum diameter of the whole nodule is \>8 mm and ≤30 mm; 6. Chest CT scan results suggest peripheral nodules which are defined as nodules in the Generation 4 or above of the airway (trachea is defined as Generation 0, left and right principal bronchi as Generation 1, lobar bronchi as Generation 2, segmental bronchi as Generation 3, and subsegmental bronchi as Generation 4); 7. Able to understand and adhere to study requirements; 8. Able to provide and sign the informed consent form. Exclusion Criteria: 1. The target nodule has been diagnosed as a malignant tumor or metastatic tumor; 2. The target nodule is later determined as a central lesion (the target nodule is in the airway, and not at a subsegmental or more distal location) during the bronchoscopy before the study procedure starts; 3. Contraindications to bronchoscopy; 4. Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3; 5. Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product; 6. Pregnancy; 7. Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure; 8. Other conditions that the investigators consider not suitable for the subjects to participate in the study; 9. Participation in any other interventional or investigational clinical studies within 30 days before enrollment.
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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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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
-
West China Hospital
Chengdu, Sichuan, China
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
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