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

Intuitive Surgical155 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Lung Cancer

Interventions

Ion Endoluminal System and Cios SpinDEVICE

Integrated version of the Ion Endoluminal System and Cios Spin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Diego, Hillcrest Medical Center

San Diego, California, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Diagnostic yield

Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied

Time frame: Intra-procedure through the 13 month follow up period

Sensitivity for malignancy

Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy

Time frame: Intra-procedure through the 13 month follow up period

Rate of tool in nodule

Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)

Time frame: Intra-procedure

Secondary Outcomes

Total radiation dose

Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm\^2)

Time frame: Intra-procedure

Time to achieve tool in nodule

Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging

Time frame: Intra-procedure

Data from ClinicalTrials.gov

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