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Real World Registry for Use of the Ion Endoluminal System

RECRUITINGSponsored by Intuitive Surgical
Actively Recruiting
SponsorIntuitive Surgical
Started2023-09-21
Est. completion2029-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations16 sites

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions10

CancerLung CancerLung DiseasesLung NeoplasmsMultiple Pulmonary NodulesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Locations16 sites

Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
Ali Jiwani, MD321-841-5111ali.jiwani@orlandohealth.com
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007
Bikash Bhattarai, MD847-437-5500bbhattarai@ilip.care
Blessing Hospital
Quincy, Illinois, 62301
Elie Chbeir, MD217-223-1200echbeir@quincymedgroup.com
Kansas University Medical Center
Kansas City, Kansas, 66103
Tulane University
New Orleans, Louisiana, 70112
Ramsy Abdelghani, MD504-988-5400rabdelgh@tulane.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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