Evaluating Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Overview

About this study

The purpose of this registry is to evaluate procedure characteristics and short and long-term patient outcomes following shape-sensing robotic-assisted bronchoscopy (ssRAB) utilizing the Ion Endoluminal System for lung lesion localization or biopsy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/24/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Janani Reisenauer, M.D.	Open for enrollment	Contact information: Thoracic Surgery Research Unit (877) 526-9172

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janani Reisenauer, M.D.

Open for enrollment

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

More information

Publications

Publications are currently not available

Clinical Trials