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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Ion Endoluminal System and Cios Spin

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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego, Hillcrest Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Texas
    • Austin, Texas, United States, 78704
      • South Austin Hospital
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin; Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin	Device: Ion Endoluminal System and Cios Spin; Integrated version of the Ion Endoluminal System and Cios Spin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied	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	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)	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	Intra-procedure

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Bryan Husta, MD, Memorial Sloan Kettering Cancer Center; Principal Investigator: Roberto Casal, MD, MD Anderson

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ISI-ION-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes