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

NCT ID: NCT04735341

Last Updated: 2022-08-09

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-09

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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Conditions

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Lung Cancer Pulmonary Nodule, Solitary

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with planned Ion Endoluminal Procedure with pulmonary nodule

Ion Endoluminal System

Intervention Type DEVICE

Ion Endoluminal Procedure for pulmonary nodule

Interventions

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Ion Endoluminal System

Ion Endoluminal Procedure for pulmonary nodule

Intervention Type DEVICE

Eligibility Criteria

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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)
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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FirstHealth of the Carolinas Moore Regional Hospital

Pinehurst, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-IonLR-001

Identifier Type: -

Identifier Source: org_study_id

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