European Real-World Registry for Use of the Ion Endoluminal System
Recruiting · NCT06923774 · Observational (researchers observe without assigning treatment) · Lead sponsor: Intuitive Surgical
View the official record on ClinicalTrials.gov →Interventions studied
Ion endoluminal system
What this trial is about
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
7 locations listed.
- Helios Klinikum Emil von Behring - Berlin, Germany
- DGD Lungenklining Hemer - Hemer, Germany
- Hôpital Marie Lannelongue - Le Plessis-Robinson, France
- University College London Hospitals NHS Foundation Trust - London, United Kingdom
- Wythenshawe Hospital, Manchester University NHS Foundation Trust - Manchester, United Kingdom
- Helios Dr. Horst Schmidt Kliniken - Wiesbaden, Germany
- Universitätsspital Zürich - Zurich, Switzerland