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Robot-Assisted lung biopsy under the microscope: will it deliver?

NCT ID NCT06004440

Knowledge-focused Sponsor: Intuitive Surgical Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking over 1,300 people who are having a lung biopsy or lesion localization with the Ion Endoluminal System, a robotic device. The goal is to see how often the device successfully gets a diagnosis and how often complications like a collapsed lung or bleeding occur. It's an observational study, meaning doctors use the device as they normally would, and researchers collect the results.

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 (a robotic-assisted device for lung biopsy)
What this could lead to
If successful, this study could confirm that the Ion system is effective and safe for routine lung biopsies, potentially improving diagnosis of lung cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove the device is better than other methods. Risks like pneumothorax or bleeding are being tracked but not compared.

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.

Participants

1,301 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Aug 2028

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.

Who is studied

Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older

Ages

18 years and older

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: * 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.

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Conditions

The condition(s) this trial relates to.

lung cancer lung disorder lung neoplasm Multiple Pulmonary Nodules neoplasm neoplasm of thorax Neoplasms by Site respiratory system disorder respiratory tract neoplasm Thoracic Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung cancer Lung diseases Lung neoplasms Multiple pulmonary nodules Neoplasms Neoplasms by site Respiratory tract diseases Respiratory tract neoplasms Thoracic neoplasms

Contacts and locations

Locations

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois, 60007, United States

  • Atrium Health of the Carolinas

    Charlotte, North Carolina, 28203, United States

  • Aurora Medical Center Kenosha

    Kenosha, Wisconsin, 53143, United States

  • Blessing Hospital

    Quincy, Illinois, 62301, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Cone Health Moses Cone Memorial Hospital

    Greensboro, North Carolina, 27401, United States

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66103, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Mercy Hospital of Buffalo

    Buffalo, New York, 14220, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Orlando Health Orlando Regional Medical Center

    Orlando, Florida, 32806, United States

  • Tulane University

    New Orleans, Louisiana, 70112, United States

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