Vanderbilt University Medical Center
Fabien Maldonado
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.
Peripheral Pulmonary Lesions
ILLUMISITE™ Platform (EMN bronchoscopy)
Ion™ Endoluminal System (SSCB bronchoscopy)
Not Applicable
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 413 participants |
Masking : | Double |
Masking Description : | It is not possible to blind the bronchoscopist or the patient to the platform used for each procedure, as they are both large distinctive-appearing pieces of equipment. However, thoracic pathologists (the outcomes assessor) and bronchoscopy schedulers (the care provider team) will remain blinded, such that allocations should be unable to influence their histopathological interpretation or scheduling of procedures in a given OR, respectively. |
Primary Purpose : | Diagnostic |
Official Title : | Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: (the RELIANT Trial) |
Actual Study Start Date : | March 6, 2023 |
Estimated Primary Completion Date : | April 9, 2024 |
Estimated Study Completion Date : | April 9, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: ILLUMISITE™ Platform (EMN bronchoscopy) Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine. |
Device: ILLUMISITE™ Platform (EMN bronchoscopy) |
Active Comparator: Ion™ Endoluminal System (SSCB bronchoscopy) 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) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232