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

Completed

• Conditions: Lung Cancer; Pulmonary Nodule
• Interventions: Device: Ion Endoluminal System

• Registration Number: NCT05160571
• Lead Sponsor: Intuitive Surgical

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-16
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Ion Endoluminal sampling of pulmonary nodule	Ion Endoluminal System	Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Primary Outcome Measures

Name	Time	Method
Sensitivity for malignancy	Intra-operative through the one year follow up period	Sensitivity for malignancy of the sample obtained
Pneumothorax	Intra-operative	Incidence of all pneumothoraces related to the Ion procedure
Diagnostic yield	Intra-operative through the one year follow up period	Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)
Bleeding	Intra-operative	Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.

Secondary Outcome Measures

Name	Time	Method
Adverse events	Intra-operative through 30 days	All adverse events related to the Ion procedure
Conversion to alternate approach or termination of procedure	Intra-operative	Rate of procedures converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., electromagnetic navigational bronchoscopy\] or a different procedure \[ex., CT-guided transthoracic needle aspiration\]) after the Ion catheter has entered the endotracheal tube. Termination is defined as prematurely ending the procedure after the Ion catheter has entered the endotracheal tube but before the biopsy sample has been obtained.

Trial Locations

Locations (1)

Winchester Medical Center; 🇺🇸 Winchester, Virginia, United States