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

Intuitive Surgical279 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

279

Conditions

Lung Cancer Pulmonary Nodule

Interventions

Ion Endoluminal SystemDEVICE

Ion Endoluminal Procedure for pulmonary nodule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Winchester Medical Center

Winchester, Virginia, United States

Outcomes

Primary Outcomes

Diagnostic yield

Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)

Time frame: Intra-operative through the one year follow up period

Sensitivity for malignancy

Sensitivity for malignancy of the sample obtained

Time frame: Intra-operative through the one year follow up period

Pneumothorax

Incidence of all pneumothoraces related to the Ion procedure

Time frame: Intra-operative

Bleeding

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.

Time frame: Intra-operative

Secondary Outcomes

Adverse events

All adverse events related to the Ion procedure

Time frame: Intra-operative through 30 days

Conversion to alternate approach or termination of procedure

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.

Data from ClinicalTrials.gov

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