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

NCT ID: NCT05546437

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-22

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection

Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion

Ion Endoluminal System

Intervention Type DEVICE

Ion Endoluminal dye marking procedure for pulmonary nodule

Interventions

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Ion Endoluminal System

Ion Endoluminal dye marking procedure for pulmonary nodule

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Orlando Health

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-ION-R02

Identifier Type: -

Identifier Source: org_study_id

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