Clinical trial NCT06004440: Real World Registry for Use of the Ion Endoluminal System
Official title: A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Keywords: pulmonary biopsy
pulmonary lesion localization
shape sensing robotic assisted bronchoscopy
ION
Intuitive
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects scheduled for an elective pulmonary lesion biopsy or localization procedure using the Ion Endoluminal System, 18 years or older

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint to Assess Diagnostic Yield
timeFrame: Intra-procedure through the 24 month follow up period
Secondary outcomes:
measure: Secondary Endpoint to Assess Pneumothorax
timeFrame: Intra-procedure through the 30 day follow up period
measure: Secondary Endpoint to Assess Bleeding
timeFrame: Intra-procedure through the 30 day follow up period
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health Orlando Regional Medical Center
state: Florida
city: Elk Grove Village
country: United States
facility: Ascension Alexian Brothers
state: Illinois
city: Quincy
country: United States
facility: Blessing Hospital
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: Mercy Hospital of Buffalo
state: New York
city: Charlotte
country: United States
facility: Atrium Health of the Carolinas
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Moses Cone Memorial Hospital
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Kenosha
country: United States
facility: Aurora Medical Center Kenosha
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: STUDY_CHAIR
affiliation: FirstHealth of the Carolinas
name: Michael Pritchett, DO, MPH
role: STUDY_CHAIR
References: