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New biopsy tool aims to sharpen lung cancer diagnosis

NCT ID NCT05562895

Diagnosis 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new integrated device that combines two systems to help doctors biopsy small lung nodules. The goal was to see if the device could improve how often the needle hits the target and how accurately it diagnoses cancer. The study involved 155 adults with lung nodules no larger than 2 cm. It was completed by Intuitive Surgical.

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 and Cios Spin (device)
What this could lead to
If successful, this could make lung nodule biopsies more accurate and safer, helping doctors diagnose lung cancer earlier.
What could go wrong
This is a completed device study, not a treatment trial. It does not test a cure or therapy, and results may not apply to all patients or nodules.

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

155 people

The number who actually took part.

Started

Dec 2022

Finished

Aug 2025

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 with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 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 procedure. * Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging. * Pulmonary nodule ≤2 cm in largest diameter. * Subject able to understand and adhere to study requirements and provide informed consent. Exclusion Criteria: * Planned lymph node staging performed before nodule biopsy. * Nodule is a pure ground glass opacity. * Plan to biopsy multiple nodules.

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Conditions

The condition(s) this trial relates to.

lung cancer lung neoplasm

As listed by the trial registrant

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

Lung cancer

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • South Austin Hospital

    Austin, Texas, 78704, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California San Diego, Hillcrest Medical Center

    San Diego, California, 92103, United States

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