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OpenTrials
Completed

NCT Number: NCT04735341

Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FirstHealth of the Carolinas Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Who can participate

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

Inclusion criteria

  • Age of 18 years or older
  • Undergoing a lung biopsy procedure with Ion System
  • Have peripheral pulmonary lesion (5th bronchial generation or higher)
  • Willingness to participate as demonstrated by signing the informed consent

Exclusion criteria

  • Unable to provide informed consent
  • Presence of bilateral nodules intended to be biopsied during procedure
  • The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
  • Vulnerable population (e.g., prisoners, mentally disabled)

Treatment and study plan

Ion Endoluminal System

Device

Ion Endoluminal Procedure for pulmonary nodule

Primary outcomes

  1. Ion Catheter Shape

    Time frame: Intra-operative

    The collection of data relating to the Ion catheter shape

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
Aug 9, 2022

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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