Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial)

Study Overview
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Brief Summary
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This is an investigator-initiated, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the Ion™ Endoluminal System (SSCB) to the ILLUMISITE™ Platform (EMN bronchoscopy) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.

Detailed Description
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Peripheral pulmonary lesions (PPLs) are often biopsied to assess for the presence of infection, inflammation, or malignancy. Tissue can be acquired in a variety of ways: surgical resection, percutaneous transthoracic needle biopsy, or bronchoscopic biopsy. Bronchoscopy is commonly pursued to determine PPL etiology, with over 500,000 performed annually in the US alone. Advanced imaging and navigational guidance systems are required to accurately approach small peripheral lesions bronchoscopically. A variety of navigational technologies are currently available, including electromagnetic navigational bronchoscopy (EMN), virtual bronchoscopy, thin and ultrathin bronchoscopes, and endobronchial ultrasound. No comparative data exist regarding the relative performance of these competing technologies, which are all considered standard of care and currently used interchangeably based on personal preferences and availability. EMN platforms dominate the current navigational bronchoscopy market. The largest prospective multicenter study assessing EMN performance showed a diagnostic yield of 73%. The more recent addition of intraprocedural digital tomosynthesis has been reported to increase EMN diagnostic yield to 75-83%; this feature is included in the ILLUMISITE™ electromagnetic navigational bronchoscopy platform (Medtronic, Minneapolis, MN, U.S.) and is labeled fluoroscopic navigation. Recently, the FDA cleared a novel navigational technology: shape-sensing catheter bronchoscopy (SSCB), via the 510(k) pathway. This pathway requires a technical demonstration of safety and efficacy similar to that of an existing predicate device but does not usually require clinical data. Since market release in 2019, single-center prospective cohort data have emerged suggesting SSCB diagnostic yield is comparable to EMN, but no high-quality comparative data exist regarding the relative performance of these two technologies. Despite this important knowledge/data gap, SSCB has become a popular platform in the advanced bronchoscopist community. High-quality comparative data are required to inform optimal patient care. Additionally, EMN and SSCB platforms are considered capital purchases, each costing hundreds of thousands of dollars. Hence, it is also important for health care systems to have high quality data as they consider device purchases. VUMC currently utilizes both SSCB and EMN and they are used interchangeably in our two operating rooms. Patients are typically assigned arbitrarily to procedures using either platform based on operating room availability. Thus, the investigator proposes a randomized controlled study to test the hypothesis that the diagnostic yield of SSCB is not inferior to EMN in patients undergoing bronchoscopy to biopsy a PPL.

Official Title
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Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial)

Conditions
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Peripheral Pulmonary Lesions

Intervention / Treatment
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* Device: ILLUMISITE™ Platform (EMN bronchoscopy)
* Device: Ion™ Endoluminal System (SSCB bronchoscopy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of bronchoscopy. Scheduled for navigational bronchoscopy for the evaluation of a peripheral pulmonary lesion. Exclusion Criteria: Enrolled in a different study requiring use of one of these specific platforms (i.e., ILLUMISITE™ Platform (EMN) or Ion™ Endoluminal System (SSCB)). Subject declines to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ILLUMISITE™ Platform (EMN bronchoscopy)<br>Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine. | Device: ILLUMISITE™ Platform (EMN bronchoscopy)<br>* Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.<br>|
| Active Comparator: Ion™ Endoluminal System (SSCB bronchoscopy)<br>Participants in the Ion™ Endoluminal System arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine. | Device: Ion™ Endoluminal System (SSCB bronchoscopy)<br>* Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield, defined as the proportion of procedures that results in acquisition of lesional tissue. Lesional tissue is defined by the presence of histopathological findings that readily explain the presence of a pulmonary lesion. | The following common histopathological findings are pre-specified as lesional: Lesional i. Malignant ii. Specific benign findings accounting for the presence of a PPL organizing pneumonia, or frank purulence/robust neutrophilic inflammation, or granulomatous inflammation, or other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns. | 7 days post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of procedure | Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures | Duration of procedure, approximately 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic navigational bronchoscopy, Shape-sensing catheter bronchoscopy, Diagnostic yield