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

NCT05562895 | Completed FDA Device

• 1 other identifier: ISI-ION-002
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Total radiation dose

  Intra-procedure

• Time to achieve tool in nodule

  Intra-procedure

Study Arms (1)

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

Interventions

Ion Endoluminal System and Cios Spin DEVICE

Integrated version of the Ion Endoluminal System and Cios Spin

Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California San Diego, Hillcrest Medical Center

San Diego, California, 92103, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

South Austin Hospital

Austin, Texas, 78704, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberto Casal, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

• Bryan Husta, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: December 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)