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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160571
• Other study ID #: ISI-ION-R01
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Pulmonary Nodule

Intervention

Device:
• Ion Endoluminal System
Ion Endoluminal Procedure for pulmonary nodule

Locations

Country	Name	City	State
United States	Winchester Medical Center	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sensitivity for malignancy	Sensitivity for malignancy of the sample obtained	Intra-operative through the one year follow up period
Primary	Pneumothorax	Incidence of all pneumothoraces related to the Ion procedure	Intra-operative
Primary	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	Adverse events	All adverse events related to the Ion procedure	Intra-operative through 30 days
Secondary	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