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Robot vs. manual: which tool best spots lung cancer?

NCT ID NCT06308120

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

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. 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

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, China

  • West China Hospital

    Chengdu, Sichuan, China

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, China

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