Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06004440

Real World Registry for Use of the Ion Endoluminal System

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orlando Health Orlando Regional Medical Center, Orlando, Florida, United States

Loading trial locations.

About this study

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.

Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is 18 years or older at the time of the index procedure.
  • Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
  • Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion criteria

  • Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
  • Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
  • Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
  • Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

Treatment and study plan

Ion Endoluminal System

Device

Subjects will under a planned procedure with the Ion Endoluminal System

Primary outcomes

  1. Primary Endpoint to Assess Diagnostic Yield

    Time frame: Intra-procedure through the 24 month follow up period

    Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.

Secondary outcomes

  1. Secondary Endpoint to Assess Pneumothorax

    Time frame: Intra-procedure through the 30 day follow up period

    Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention

  2. Secondary Endpoint to Assess Bleeding

    Time frame: Intra-procedure through the 30 day follow up period

    Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2023
Registry last updated
Apr 24, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.