RECRUITING

Real World Registry for Use of the Ion Endoluminal System

Description

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

Conditions

Lung CancerMultiple Pulmonary NodulesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases
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Related Conditions:

Lung CancerMultiple Pulmonary NodulesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Overview

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Study Details

Study overview

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Real World Registry for Use of the Ion Endoluminal System

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Davis

University of California Davis Medical Center, Davis, California, United States, 95616

Orlando

Orlando Health Orlando Regional Medical Center, Orlando, Florida, United States, 32806

Elk Grove Village

Ascension Alexian Brothers, Elk Grove Village, Illinois, United States, 60007

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66103

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

Greensboro

Cone Health Moses Cone Memorial Hospital, Greensboro, North Carolina, United States, 27401

Pinehurst

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina, United States, 28374

Columbus

Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Nashville

Centennial Medical Center, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Intuitive Surgical,

Janani Reisenauer, MD, STUDY_CHAIR, Mayo Clinic

Michael Pritchett, DO, MPH, STUDY_CHAIR, FirstHealth of the Carolinas

Study Record Dates

2027-08