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.

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

Peripheral Pulmonary Lesions

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.

ILLUMISITE™ Platform (EMN bronchoscopy)

Ion™ Endoluminal System (SSCB bronchoscopy)

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.

Professor of Medicine and Thoracic Surgery, MD, MSc

Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures

Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.

Participants in the Ion™ Endoluminal System arm will undergo a diagnostic bronchoscopy with the Ion™ Endoluminal System (SSCB) machine.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status