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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Pulmonary Nodule
• Intervention / Treatment: Device: Ion Endoluminal 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 Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

• Study Contact: Name: Alison Gorski; Phone Number: (408) 523-1855; Email: alison.gorski@intusurg.com
• Study Contact Backup: Name: Sundeep Master; Phone Number: (408) 523-1045; Email: sundeep.master@intusurg.com

Study Locations

• United States
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who underwent an Ion Endoluminal Procedure with a pulmonary nodule, 18 years or older

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Ion Endoluminal sampling of pulmonary nodule; Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System	Device: Ion Endoluminal System; Ion Endoluminal Procedure for pulmonary nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Intra-operative through the one year follow up period
Sensitivity for malignancy	Sensitivity for malignancy of the sample obtained	Intra-operative through the one year follow up period
Pneumothorax	Incidence of all pneumothoraces related to the Ion procedure	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.	Intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All adverse events related to the Ion procedure	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.	Intra-operative

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Glen Bouder, MD, Winchester Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: ISI-ION-R01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No