European Real-World Registry for Use of the Ion Endoluminal System

August 3, 2026 updated by: Intuitive Surgical

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

The objective of this study is to collect collect real-world data for the Ion endoluminal system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Le Plessis-Robinson, France, 92350
        • Recruiting
        • Hôpital Marie Lannelongue
        • Contact:
          • Amir Hanna, Dr.
  • Germany
      • Berlin, Germany, 14165
        • Recruiting
        • Helios Klinikum Emil von Behring
        • Contact:
          • Joanna Krist, Dr.
      • Hemer, Germany, 58675
        • Not yet recruiting
        • DGD Lungenklining Hemer
        • Contact:
          • Kaid Darwiche, Prof. Dr.
      • Wiesbaden, Germany, 65199
        • Not yet recruiting
        • Helios Dr. Horst Schmidt Kliniken
        • Contact:
          • Tim Hirche, Prof. Dr.
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitätsspital Zürich
        • Contact:
          • Carolin Steinack, PD Dr.
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
          • Ricky Thakrar, Dr.
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital, Manchester University NHS Foundation Trust
        • Contact:
          • Haval Balata, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients planned for an elective lung nodule biopsy and/or localization procedure using the Ion endoluminal system as their standard of care

Description

Inclusion Criteria:

  • Patient is aged 18 years or older at time of consent.
  • Patient is planned to undergo a lung lesion biopsy(s) and/or localization procedure(s) utilizing the Ion endoluminal system.
  • Patient is willing and able to give written informed consent for clinical study participation.

Exclusion Criteria:

  • Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
  • Female patient that is pregnant or breast feeding as determined by standard site practices.
  • Patient is legally incapacitated or in a legal/court ordered institution or is part of a known vulnerable population, including but not limited to dependency on the sponsor, hospital or study doctor.
  • Patient is not willing to comply with post-procedure study participation requirements.
  • Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observation Group
Subjects with biopsy and/or localization of lung nodule(s)
Device: Ion endoluminal system
Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic Yield
Time Frame: Intra-procedure through 24 month post-procedure
Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
Intra-procedure through 24 month post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pneumothorax
Time Frame: Intra-procedure through 30 days post-procedure
Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention
Intra-procedure through 30 days post-procedure
Bleeding
Time Frame: Intra-procedure through the 30 day post-procedure
Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale
Intra-procedure through the 30 day post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intuitive Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1147383C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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