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OpenTrials
Completed

NCT Number: NCT05562895

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ion Endoluminal System and Cios Spin

Device

Integrated version of the Ion Endoluminal System and Cios Spin

Primary outcomes

  1. Diagnostic yield

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

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

  2. Sensitivity for malignancy

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

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

  3. Rate of tool in nodule

    Time frame: Intra-procedure

    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)

Secondary outcomes

  1. Total radiation dose

    Time frame: Intra-procedure

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

  2. Time to achieve tool in nodule

    Time frame: Intra-procedure

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

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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