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Real World Registry for Use of the Ion Endoluminal System

NCT ID: NCT06004440

Last Updated: 2025-11-13

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

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-21

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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pulmonary biopsy pulmonary lesion localization shape sensing robotic assisted bronchoscopy ION Intuitive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with biopsy, with or without localization, of pulmonary lesion using Ion Endoluminal System

Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.

Ion Endoluminal System

Intervention Type DEVICE

Subjects will under a planned procedure with the Ion Endoluminal System

Interventions

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Ion Endoluminal System

Subjects will under a planned procedure with the Ion Endoluminal System

Intervention Type DEVICE

Eligibility Criteria

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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.
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

Principal Investigators

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Janani Reisenauer, MD

Role: STUDY_CHAIR

Mayo Clinic

Michael Pritchett, DO, MPH

Role: STUDY_CHAIR

FirstHealth of the Carolinas

Locations

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Orlando Health Orlando Regional Medical Center

Orlando, Florida, United States

Site Status RECRUITING

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States

Site Status RECRUITING

Blessing Hospital

Quincy, Illinois, United States

Site Status RECRUITING

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

Tulane University

New Orleans, Louisiana, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Mercy Hospital of Buffalo

Buffalo, New York, United States

Site Status RECRUITING

Atrium Health of the Carolinas

Charlotte, North Carolina, United States

Site Status RECRUITING

Cone Health Moses Cone Memorial Hospital

Greensboro, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Centennial Medical Center

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Methodist Hospital

San Antonio, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status RECRUITING

Aurora Medical Center Kenosha

Kenosha, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Heather Golden, MSc, CCRP

Role: CONTACT

Phone: 8105697006

Email: [email protected]

Lindsay Spotanski, BSc, CCRP

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ali Jiwani, MD

Role: primary

Bikash Bhattarai, MD

Role: primary

Elie Chbeir, MD

Role: primary

Ramsy Abdelghani, MD

Role: primary

Angel R Peralta, MD

Role: primary

Janani Reisenauer, MD

Role: primary

Nirosshan Thiruchelvam, MD

Role: primary

Jaspal Singh, MD

Role: primary

Timothy LeClair, MD

Role: primary

Other Identifiers

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IntuitiveSurgical

Identifier Type: -

Identifier Source: org_study_id