Trial Title:
Real World Registry for Use of the Ion Endoluminal System
NCT ID:
NCT06004440
Condition:
Lung Cancer
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Conditions: Official terms:
Neoplasms
Lung Neoplasms
Multiple Pulmonary Nodules
Neoplasms by Site
Thoracic Neoplasms
Respiratory Tract Neoplasms
Lung Diseases
Respiratory Tract Diseases
Conditions: Keywords:
pulmonary biopsy
pulmonary lesion localization
shape sensing robotic assisted bronchoscopy
ION
Intuitive
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Ion Endoluminal System
Description:
Subjects will under a planned procedure with the Ion Endoluminal System
Arm group label:
Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System
Summary:
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.
Detailed description:
This study is a single-arm, post-market, prospective, multi-center, observational study
of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion
localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of
this study is focused on evaluating the performance characteristics of the pulmonary
lesion biopsy procedure as evaluated by diagnostic yield.
Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the
Public Health Service Act and 42 CFR 11.60.
Criteria for eligibility:
Study pop:
Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure
using the Ion Endoluminal System, 18 years or older
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Davis Medical Center
Address:
City:
Davis
Zip:
95616
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Tina Tham, CCRP
Investigator:
Last name:
Chinh Phan, DO
Email:
Principal Investigator
Facility:
Name:
Orlando Health Orlando Regional Medical Center
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kathleen Sanders, MBA, CCRP
Investigator:
Last name:
Ali Z. Jiwani, MD
Email:
Principal Investigator
Facility:
Name:
Ascension Alexian Brothers
Address:
City:
Elk Grove Village
Zip:
60007
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diana Sullivan, MS, RN
Investigator:
Last name:
Neeraj Desai, MD
Email:
Principal Investigator
Facility:
Name:
Kansas University Medical Center
Address:
City:
Kansas City
Zip:
66103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Quigley, RRT, CCRC
Investigator:
Last name:
Maykol Postigo, MD
Email:
Principal Investigator
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Sherae Hereford, RN
Investigator:
Last name:
A. Rolando Peralta, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karly Pierson, RN, CCRP
Investigator:
Last name:
Janani Reisenauer, MD
Email:
Principal Investigator
Facility:
Name:
Cone Health Moses Cone Memorial Hospital
Address:
City:
Greensboro
Zip:
27401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Iulia Basaraba, MD
Investigator:
Last name:
Bradley Icard, DO
Email:
Principal Investigator
Facility:
Name:
FirstHealth Moore Regional Hospital
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julie Williams, PhD, MPH
Investigator:
Last name:
Michael Prichett, DO, MPH
Email:
Principal Investigator
Facility:
Name:
Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Miller
Investigator:
Last name:
Alberto Revelo, MD
Email:
Principal Investigator
Facility:
Name:
Centennial Medical Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sean O'Malley, RN, BSN
Investigator:
Last name:
Susan Garwood, MD
Email:
Principal Investigator
Facility:
Name:
Methodist Hospital
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samantha Franklin
Investigator:
Last name:
Ali Abedi, MD, MSc
Email:
Principal Investigator
Facility:
Name:
Intermountain Medical Center
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Valerie Aston, MBA, CCRP
Investigator:
Last name:
Timothy LeClair, MD
Email:
Principal Investigator
Facility:
Name:
Aurora Medical Center Kenosha
Address:
City:
Kenosha
Zip:
53143
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Dina Yassen, MBBS
Investigator:
Last name:
Hasnain Bawaadam, MD, MPH
Email:
Principal Investigator
Start date:
September 21, 2023
Completion date:
August 2027
Lead sponsor:
Agency:
Intuitive Surgical
Agency class:
Industry
Source:
Intuitive Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06004440
