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Completed

NCT Number: NCT05546437

A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms 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, Florida, 32806, United States

About this study

This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

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 procedure.
  • Dye marking attempted/performed using the Ion Endoluminal Platform

Exclusion criteria

  • Resection not performed following dye marking procedure

Treatment and study plan

Ion Endoluminal System

Device

Ion Endoluminal dye marking procedure for pulmonary nodule

Primary outcomes

  1. Successful dye injection

    Time frame: Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure

    The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample

  2. Pneumothorax

    Time frame: Intra-procedure

    Incidence of all pneumothoraces related to the Ion procedure

Secondary outcomes

  1. Adverse events

    Time frame: Intra-procedure until the start of the resection procedure

    All adverse events related to the Ion procedure

  2. Procedure time

    Time frame: Intra-procedure

    Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube [ETT]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT).

  3. Operative time

    Time frame: Intra-operative

    Time from start of resection procedure to end of resection procedure (skin-to-skin time)

  4. Type of resection planned and performed

    Time frame: Intra-operative

    The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started.

  5. Conversion to alternate approach or termination of procedure due to localization issues

    Time frame: Intra-operative

    Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., open resection] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2022
Registry last updated
Mar 8, 2024

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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