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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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
        • Universitatsspital Zurich
        • 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

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
Intervention / Treatment
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

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

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

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)

September 9, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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