A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

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

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

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This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

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Detailed Description

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This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

Conditions

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Lung Cancer Pulmonary Nodule

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects with Ion Endoluminal sampling of pulmonary nodule

Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Ion Endoluminal System

Intervention Type DEVICE

Ion Endoluminal Procedure for pulmonary nodule

Interventions

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Ion Endoluminal System

Ion Endoluminal Procedure for pulmonary nodule

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject was 18 years or older at the time of the procedure
* Biopsy procedure attempted/performed using the Ion Endoluminal System

Exclusion Criteria

* Biopsy procedure was not attempted with the Ion Endoluminal System
* Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No