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Pulmonary Nodule, SolitaryARTICULAtENCT06308120

A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

A study testing Ion Endoluminal System and superDimension Navigation System and Accessories in people with Pulmonary Nodule, Solitary and Lung Cancer, run by Intuitive Surgical at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pulmonary Nodule, Solitary, Lung Cancer
What is being tested?
Ion Endoluminal System and superDimension Navigation System and Accessories
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
3 sitesChina
Study dates
20 Mar 2024to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to tolerate bronchoscopy;
  • ≥18 years and ≤ 80 years;
  • Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation*;
  • The pulmonary nodules are solid or part-solid;
  • The maximum diameter of the whole nodule is >8 mm and ≤30 mm;
  • 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);
  • Able to understand and adhere to study requirements;
  • Able to provide and sign the informed consent form.

Who cannot join

  • The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
  • 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;
  • Contraindications to bronchoscopy;
  • Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
  • Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
  • Pregnancy;
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  • Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
  • Other conditions that the investigators consider not suitable for the subjects to participate in the study;
  • Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • West China Hospital

    Chengdu, Sichuan

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized Controlled Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.

Read the detailed description

Lung cancer is the malignant tumor with the highest morbidity and mortality in the world. Besides the aggressive nature of lung cancer, the overall high cancer mortality is mainly associated with the time delay between cancer development and initial clinical symptoms.

In the past, bronchoscope was mainly used to biopsy the nodules in the central airway but played a limited role in managing peripheral nodules due to its low diagnosis accuracy in such nodules. Advanced bronchoscopic techniques include tools for bronchoscopic guidance such as guide sheath (GS), Endobronchial Ultrasound (EBUS), Electromagnetic Navigation (ENB), or Virtual Bronchoscopic Navigation (VBN). In well-designed clinical studies, these techniques can be used to increase the diagnostic yield of flexible bronchoscope in dealing with peripheral nodules. However, the real-world registry study data showed that the diagnostic yield of these techniques in practice is as low as 53.7 %.. More importantly, these advanced bronchoscopic techniques haven't been widely used or become standard treatments in China mainly due to high skill requirements and high costs.

ION™ Endoluminal System is a robotic-assisted system which assists the user in navigating a catheter and endoscopic tools in the pulmonary tract under bronchial endoscope for diagnostic and therapeutic procedures. The fully articulating catheter with a small outer diameter of 3.5 mm can enter the small airways around the lungs with navigation enabled by shape-sensing technology and not electromagnetics; the shape sensing fiber provides instant feedbacks on shapes and locations during navigation and biopsy. The tool channel with an inner diameter of 2 mm for the catheter is compatible with various biopsy tools.

The purpose of this study a randomized controlled study to test the hypothesis that the diagnostic yield of ION™ is Superior to electromagnetic navigation bronchoscopy in patients undergoing bronchoscopy to biopsy a peripheral pulmonary nodule (PPN).

Being tested
Ion Endoluminal System, superDimension Navigation System and Accessories
Medical subject headings
Solitary Pulmonary Nodule, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ion Endoluminal SystemDevice

    Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

  • superDimension Navigation System and AccessoriesDevice

    Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

Study groups in NCT06308120
Study groupRoleWhat they receive
ION™ Endoluminal SystemActive comparatorION™ Endoluminal System Providers will utilize the ION™ Endoluminal System to perform a diagnostic bronchoscopy procedure
Receives: Device: Ion Endoluminal System
superDimension Navigation System and AccessoriesActive comparatorProviders will utilize the superDimension Navigation System and Accessories to perform a diagnostic bronchoscopy procedure.
Receives: Device: superDimension Navigation System and Accessories

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Yield

    Diagnostic yield=number of study procedures in which a true positive for malignancy or a specific benign result is diagnosed by biopsy or non-specific benign is confirmed at the follow-up 6 months after procedure/total number of study procedures of each group ×100 %

    Measured: Index Procedure

Secondary outcomes (4)

  1. Sensitivity for malignancy of biopsy obtained samples

    Diagnostic sensitivity of malignancies=number of cases diagnosed with malignancies by study procedure / number of causes with malignancies in each group * 100 %

    Measured: 6 months post-procedure

  2. Incidence of pneumothorax that requires chest tube placement and/or re-hospitalization or extended hospitalization

    Pneumothorax is graded according to CTCAE 5.0. and differentiated according to the necessity to place a chest tube, readmission to the hospital, or prolonged hospitalization.

    Measured: 1 month post-procedure

  3. Incidence of intraoperative severe airway bleeding

    Severe airway bleeding is defined as Grade 3 or above per Nashville Delphi scale (2020).

    Measured: Intra-procedure

  4. Diagnostic yield

    Diagnostic yield assessed using the intermediate definition inclusive of follow-up data

    Measured: 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start20 Mar 2024
  3. Primary completion10 Dec 2025
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Stratified, randomized controlled trial with parallel group assignment. The first 90 subjects are not randomized and only include the study device for a lead-in period.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308120
Sponsor's protocol ID
ISI-IONCN-002
Acronym
ARTICULAtE
Status last verified
Apr 2026
First submitted
6 Mar 2024
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Liu D, Li C, Xie F, Hu X, Shi J, Liu Z, Liu J, Simoff MJ, Song Y, Sun J. Shape-sensing robotic-assisted bronchoscopy (ss-RAB) for peripheral pulmonary nodules: learning curve and diagnostic performance from an initial multicenter experience in China. Respir Res. 2026 Jan 26;27(1):140. doi: 10.1186/s12931-025-03488-z.

    PubMed 41588450

  • Xie F, Zhang C, Li C, Liu D, Song Y, Simoff MJ, Sun J. Protocol for robotic-assisted bronchoscopy versus electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules: a randomized trial (ARTICULAtE study). J Thorac Dis. 2025 Jun 30;17(6):4339-4348. doi: 10.21037/jtd-2025-312. Epub 2025 Jun 26.

    PubMed 40688277

Questions about this trial

What is this clinical trial studying?

A study testing Ion Endoluminal System and superDimension Navigation System and Accessories in people with Pulmonary Nodule, Solitary and Lung Cancer, run by Intuitive Surgical at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Yield (time frame: Index Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308120, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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