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

NCT06923774 | Recruiting

• 1 other identifier: 1147383C
• Study Type: observational
• Target: 1,200
• Locations: 4 countries
• Sites: 5

Brief Summary

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

Conditions

Pulmonary Nodule; Lung Cancer

Keywords

Biopsy; Bronchoscopy; pulmonary biopsy; pulmonary nodule localization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pneumothorax

  Intra-procedure through 30 days post-procedure

• Bleeding

  Intra-procedure through the 30 day post-procedure

Study Arms (1)

Observation Group

Subjects with biopsy and/or localization of lung nodule(s)

Device: Ion endoluminal system

Interventions

Ion endoluminal system DEVICE

Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care

Observation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (5)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

NOT YET RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jana Meschede

CONTACT

+41 21 821 2000; IonEURegistry@intusurg.com

Martha Bean

CONTACT

+41 21 821 2000; IonEURegistry@intusurg.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CH (1); DE (1); GB (2)