To hear about similar clinical trials, please enter your email below
Trial Title:
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
NCT ID:
NCT05562895
Condition:
Lung Cancer
Conditions: Official terms:
Multiple Pulmonary Nodules
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Ion Endoluminal System and Cios Spin
Description:
Integrated version of the Ion Endoluminal System and Cios Spin
Arm group label:
Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal
System and Cios Spin, 18 years or older
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Planned lymph node staging performed before nodule biopsy.
- Nodule is a pure ground glass opacity.
- Plan to biopsy multiple nodules.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Facility:
Name:
University of California San Diego, Hillcrest Medical Center
Address:
City:
San Diego
Zip:
92103
Country:
United States
Facility:
Name:
Mayo Clinic - Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
South Austin Hospital
Address:
City:
Austin
Zip:
78704
Country:
United States
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
December 31, 2022
Completion date:
January 31, 2025
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/NCT05562895
