Not currently recruiting at University of California Health

Real World Registry for Use of the Ion Endoluminal System

a study on Lung Cancer Multiple Pulmonary Nodules Lung Tumor Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms Lung Diseases Respiratory Tract Diseases

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Chinh Phan, DO (ucdavis)

Description

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.

Official Title

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

Details

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.

Keywords

Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, pulmonary biopsy, pulmonary lesion localization, shape sensing robotic assisted bronchoscopy, ION, Intuitive, Ion Endoluminal System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Davis Medical Center not yet accepting patients
    Davis California 95616 United States
  • Intermountain Medical Center not yet accepting patients
    Murray Utah 84107 United States
  • Methodist Hospital accepting new patients
    San Antonio Texas 78229 United States
  • Kansas University Medical Center accepting new patients
    Kansas City Kansas 66103 United States

Lead Scientist at University of California Health

  • Chinh Phan, DO (ucdavis)
    Associate Professor of Clinical, MED: Int Med Pulmonary, Critical Care, and Sleep Medicine, School of Medicine. Authored (or co-authored) 10 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Intuitive Surgical
ID
NCT06004440
Study Type
Observational [Patient Registry]
Participants
Expecting 3000 study participants
Last Updated