European Real-World Registry for Use of the Ion Endoluminal System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ion endoluminal system.
- Who it may be relevant to
- Registry conditions: Pulmonary Nodule, Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Switzerland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
Overview
The objective of this study is to collect collect real-world data for the 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.
Interventions
- Device Ion endoluminal system
Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
Primary outcome measures
- Diagnostic Yield [Time frame: Intra-procedure through 24 month post-procedure]
Secondary outcome measures (2)
- Pneumothorax [Time frame: Intra-procedure through 30 days post-procedure]
- Bleeding [Time frame: Intra-procedure through the 30 day post-procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Helios Klinikum Emil von Behring — Berlin
- DGD Lungenklining Hemer — Hemer
- Helios Dr. Horst Schmidt Kliniken — Wiesbaden
United Kingdom · 2 centers
- University College London Hospitals NHS Foundation Trust — London
- Wythenshawe Hospital, Manchester University NHS Foundation Trust — Manchester
France · 1 center
- Hôpital Marie Lannelongue — Le Plessis-Robinson
Switzerland · 1 center
- Universitätsspital Zürich — Zurich
Identifiers
NCT: NCT06923774 · 1147383C