This study is in progress, not accepting new patients

A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

a study on Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

Summary

The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.

Details

This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.

Keywords

Lung Cancer, Multiple Pulmonary Nodules, Ion Endoluminal System and Cios Spin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject is 18 years or older at the time of the procedure.
  • Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
  • Pulmonary nodule ≤2 cm in largest diameter.
  • Subject able to understand and adhere to study requirements and provide informed consent.

You CAN'T join if...

  • Planned lymph node staging performed before nodule biopsy.
  • Nodule is a pure ground glass opacity.
  • Plan to biopsy multiple nodules.

Locations

  • University of California San Diego, Hillcrest Medical Center
    San Diego California 92103 United States
  • South Austin Hospital
    Austin Texas 78704 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intuitive Surgical
ID
NCT05562895
Study Type
Observational
Participants
About 155 people participating
Last Updated