Status:
RECRUITING
European Real-World Registry for Use of the Ion Endoluminal System
Lead Sponsor:
Intuitive Surgical
Conditions:
Pulmonary Nodule
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06923774
Start Date
September 9 2025
End Date
October 1 2029
Last Update
November 21 2025
Active Locations (4)
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1
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, 92350
2
Universitätsspital Zürich
Zurich, Switzerland, 8091
3
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
4
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, United Kingdom, M23 9LT