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

Launched by INTUITIVE SURGICAL · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to gather real-world information about a device called the Ion endoluminal system, which is used for biopsying lung nodules. A lung nodule is a small growth in the lung that may or may not indicate lung cancer. The goal of the study is to better understand how this system works in everyday medical settings and how it can help patients who need lung biopsies or localization procedures.

To be eligible for this trial, participants must be at least 18 years old and scheduled to undergo a biopsy using the Ion system. They must also be willing to give consent to join the study. However, some individuals may not be able to participate, such as those who are pregnant or breastfeeding, those currently involved in other conflicting research studies, or those who the doctor believes should not take part for safety reasons. If you join the trial, you can expect to follow certain guidelines after the procedure to help gather important data for the study. It’s a chance to contribute to medical knowledge that could help improve lung cancer care in the future.

Gender

ALL

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.