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

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Device: Ion Endoluminal System and Cios Spin

• Registration Number: NCT05562895
• Lead Sponsor: Intuitive Surgical

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.

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 Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2022-12-31
• Primary Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	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
Sensitivity for malignancy	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
Rate of tool in nodule	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 Outcome Measures

Name	Time	Method
Total radiation dose	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)
Time to achieve tool in nodule	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

Trial Locations

Locations (6)

University of California San Diego, Hillcrest Medical Center; 🇺🇸 San Diego, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

South Austin Hospital; 🇺🇸 Austin, Texas, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States