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Completed

NCT Number: NCT05160571

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pulmonary Nodule Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Winchester Medical Center

Winchester, Virginia, 22601, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ion Endoluminal System

Device

Ion Endoluminal Procedure for pulmonary nodule

Primary outcomes

  1. Diagnostic yield

    Time frame: 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)

  2. Sensitivity for malignancy

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

    Sensitivity for malignancy of the sample obtained

  3. Pneumothorax

    Time frame: Intra-operative

    Incidence of all pneumothoraces related to the Ion procedure

  4. Bleeding

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: Intra-operative through 30 days

    All adverse events related to the Ion procedure

  2. Conversion to alternate approach or termination of procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2021
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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