RECRUITING

Real World Registry for Use of the Ion Endoluminal System

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Conditions

Lung CancerMultiple Pulmonary NodulesLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseasespulmonary biopsypulmonary lesion localizationshape sensing robotic assisted bronchoscopyIONIntuitive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-21
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06004440

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is 18 years or older at the time of the index procedure.
  2. * Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
  3. * Subject able to understand and adhere to study requirements and provide informed consent.
  1. * Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
  2. * 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.
  3. * Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
  4. * Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

Contacts and Locations

Study Contact

Heather Golden, MSc, CCRP
CONTACT
8105697006
heather.golden@intusurg.com
Lindsay Seibel, BSc
CONTACT
Lindsay.Seibel@intusurg.com

Principal Investigator

Janani Reisenauer, MD
STUDY_CHAIR
Mayo Clinic
Michael Pritchett, DO, MPH
STUDY_CHAIR
FirstHealth of the Carolinas

Study Locations (Sites)

University of California Davis Medical Center
Davis, California, 95616
United States
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
United States
Kansas University Medical Center
Kansas City, Kansas, 66103
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Cone Health Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Centennial Medical Center
Nashville, Tennessee, 37203
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
Aurora Medical Center Kenosha
Kenosha, Wisconsin, 53143
United States

Collaborators and Investigators

Sponsor: Intuitive Surgical

  • Janani Reisenauer, MD, STUDY_CHAIR, Mayo Clinic
  • Michael Pritchett, DO, MPH, STUDY_CHAIR, FirstHealth of the Carolinas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-21
Study Completion Date2027-08

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • pulmonary biopsy
  • pulmonary lesion localization
  • shape sensing robotic assisted bronchoscopy
  • ION
  • Intuitive

Additional Relevant MeSH Terms

  • Lung Cancer
  • Multiple Pulmonary Nodules
  • Lung Neoplasms
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Lung Diseases
  • Respiratory Tract Diseases