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

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: Lung Cancer; Pulmonary Nodule
• Intervention / Treatment: Device: Ion endoluminal system

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

• Study Contact: Name: Jana Meschede; Phone Number: +41 21 821 2000; Email: IonEURegistry@intusurg.com
• Study Contact Backup: Name: Martha Bean; Phone Number: +41 21 821 2000; Email: IonEURegistry@intusurg.com

Study Locations

• France
  • Le Plessis-Robinson, France, 92350
    • Recruiting
    • Hopital Marie Lannelongue
    • Contact: Amir Hanna, Dr.
• Germany
  • Berlin, Germany, 14165
    • Not yet recruiting
    • Helios Klinikum Emil Von Behring
    • Contact: Joanna Krist, Dr.
• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • Universitatsspital Zurich
    • Contact: Thomas Gaisl, 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

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

How is the study designed?

Number of groups / cohorts

1

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	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	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	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

• Sponsor: Intuitive Surgical

Study record dates

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): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Bronchoscopy; Biopsy; pulmonary biopsy; pulmonary nodule localization
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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