Real World Registry for Use of the Ion Endoluminal System

Launched by INTUITIVE SURGICAL · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well the Ion Endoluminal System works for locating and taking samples from lung lesions, which are abnormal growths in the lungs. The goal is to see how effective this system is when used in real-life situations, outside of a controlled lab environment. The trial is currently recruiting participants who are 18 years or older and who need a planned procedure to locate or biopsy a lung lesion using this system.

To be eligible for the study, participants must be able to understand the study's requirements and provide consent on their own. However, those who are pregnant, nursing, or unable to give consent due to certain conditions cannot participate. If you join the study, you can expect to undergo a procedure that uses the Ion Endoluminal System to help doctors understand more about your lung condition. This research aims to improve how doctors diagnose and treat lung diseases, potentially benefiting many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is 18 years or older at the time of the index procedure.
• • Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
• • Subject able to understand and adhere to study requirements and provide informed consent.
• Exclusion Criteria:
• • Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
• • Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
• • Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
• • Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.