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Evaluating the Ion Endoluminal System for lung lesion procedures

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Observational Intuitive Surgical · NCT06004440

This study is testing a new robotic tool to see if it can help doctors find and take samples from lung lesions more effectively in patients needing a biopsy.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorIntuitive Surgical Industry-sponsored
Locations16 sites (Orlando, Florida and 15 other locations)
Trial IDNCT06004440 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance of the Ion Endoluminal System in real-world settings for the localization and biopsy of pulmonary lesions. It is a single-arm, post-market, prospective study conducted across multiple centers, focusing on patients undergoing robotic-assisted bronchoscopy. The primary outcome is to evaluate the diagnostic yield of the biopsy procedures performed using this innovative technology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for a lung lesion localization or biopsy using the Ion Endoluminal System.

Not a fit: Patients who are pregnant, nursing, or unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy and effectiveness of lung lesion biopsies, leading to better patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving biopsy techniques, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subject is 18 years or older at the time of the index procedure.
* Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
* Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion Criteria:

* Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
* Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
* Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
* Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

Where this trial is running

Orlando, Florida and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung CancerMultiple Pulmonary NodulesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.