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

NCT ID: NCT05562895

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-31

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Ion Endoluminal System and Cios Spin

Intervention Type DEVICE

Integrated version of the Ion Endoluminal System and Cios Spin

Interventions

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Ion Endoluminal System and Cios Spin

Integrated version of the Ion Endoluminal System and Cios Spin

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto Casal, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson

Bryan Husta, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California San Diego, Hillcrest Medical Center

San Diego, California, United States

Site Status

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

South Austin Hospital

Austin, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-ION-002

Identifier Type: -

Identifier Source: org_study_id