Actively Recruiting
A European Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Ion Endoluminal System
Led by Intuitive Surgical · Updated on 2026-03-24
1200
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting real-world data to evaluate the Ion endoluminal system, a device used for lung nodule biopsies and localization procedures. This observational study involves multiple centers across Europe and aims to understand the procedural details and both short- and long-term clinical outcomes following the use of this CE-marked device. The research focuses on elective procedures performed according to approved indications. Participants will undergo lung lesion biopsy and/or localization using the Ion endoluminal system as part of their standard care. This single-arm study does not involve comparison groups, and all patients who meet eligibility criteria will be enrolled. The study plans to include about 1,200 patients who have had a biopsy or localization procedure attempted or completed. During the study, researchers will collect information on diagnostic success from the procedure through 24 months afterward. They will also monitor for complications such as pneumothorax and bleeding within 30 days post-procedure. Participants will be followed over time to gather data on outcomes, with the study expected to continue until 2029. Patients' adherence to post-procedure follow-up is important for the study's success.
CONDITIONS
Brief Title
European Real-World Registry for Use of the Ion Endoluminal System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo lung nodule biopsy and/or localization procedures using the Ion endoluminal system per standard care.
1 procedure visit (in-person)
Duration - Up to 24 months post-procedure
Participants are followed to evaluate short- and long-term outcomes after the procedure.
Follow-up visits up to 24 months post-procedure as per routine care
Trial Site Locations
Total: 5 locations
1
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, 92350
Actively Recruiting
2
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
Not Yet Recruiting
3
Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
4
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Actively Recruiting
5
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Actively Recruiting
Research Team
J
Jana Meschede
M
Martha Bean
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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