An interventional study of ILLUMISITE™ Platform (EMN bronchoscopy) and Ion™ Endoluminal System (SSCB bronchoscopy) in Peripheral Pulmonary Lesions, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic
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 (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.
Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participants in the ILLUMISITE™ Platform arm will undergo a diagnostic bronchoscopy with the ILLUMISITE™ Platform (EMN) machine.
Device: ILLUMISITE™ Platform (EMN 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)
Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.
Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.
Diagnostic Yield
Diagnostic yield is 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: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL 1. organizing pneumonia, or 2. frank purulence/robust neutrophilic inflammation, or 3. granulomatous inflammation, or 4. other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns.
Time frame: 7 days post-enrollment
Duration of Procedure
Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures
Time frame: Duration of procedure, approximately 60 minutes
| Milestone | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) |
|---|---|---|
| Started | 208 | 203 |
| Completed | 208 | 203 |
| Not completed | 0 | 0 |
Diagnostic yield is 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: i. Malignant ii. "Specific benign" findings accounting for the presence of a PPL 1. organizing pneumonia, or 2. frank purulence/robust neutrophilic inflammation, or 3. granulomatous inflammation, or 4. other specific benign finding findings such as hamartoma, amyloidoma or other uncommon causes of PPLs with distinctive pathological patterns.
| Participants | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) |
|---|---|---|
| Diagnostic Yield | 157 | 158 |
Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures
| minutes | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) |
|---|---|---|
| Duration of Procedure | 32.0 (25.0 to 43.3) | 37.0 (29.0 to 48.0) |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ILLUMISITE™ Platform (EMN Bronchoscopy) | 0/208 (0%) | 7/208 (3.4%) | 5/208 (2.4%) |
| Ion™ Endoluminal System (SSCB Bronchoscopy) | 0/203 (0%) | 5/203 (2.5%) | 0/203 (0%) |
| Event | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) |
|---|---|---|
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 6/208 | 4/203 |
| Anesthesia ComplicationInjury, poisoning and procedural complications | 1/208 | 1/203 |
| Event | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) |
|---|---|---|
| Persistent dyspnea post-procedureRespiratory, thoracic and mediastinal disorders | 2/208 | 0/203 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/208 | 0/203 |
| COPD ExacerbationRespiratory, thoracic and mediastinal disorders | 1/208 | 0/203 |
| Persistent CoughRespiratory, thoracic and mediastinal disorders | 1/208 | 0/203 |
| Age, Continuous(years) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Median | 67.0 (59.0 to 75.0) | 69.0 (61.0 to 74.0) | 67.0 (60.0 to 74.5) |
| Sex: Female, Male(Participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Female | 100 | 101 | 201 |
| Male | 108 | 102 | 210 |
| Race/Ethnicity, Customized(Participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Race — White | 189 | 188 | 377 |
| Race — Black or African American | 15 | 15 | 30 |
| Race — Asian | 3 | 0 | 3 |
| Race — Unknown or unable to report | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Ethnicity — Non-Hispanic | 202 | 198 | 400 |
| Ethnicity — Hispanic | 6 | 5 | 11 |
| Region of Enrollment(participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| United States | 208 | 203 | 411 |
| Current malignancy(Participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Count of participants | 42 | 51 | 93 |
| Prior malignancy(Participants) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Count of participants | 73 | 71 | 144 |
| Body Mass Index, median(Kg/m^2) | ILLUMISITE™ Platform (EMN Bronchoscopy) | Ion™ Endoluminal System (SSCB Bronchoscopy) | Total |
|---|---|---|---|
| Median | 26.8 (23.9 to 30.4) | 26.5 (23.0 to 30.6) | 26.6 (23.4 to 30.5) |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
Supporting information: Study protocol, Sap
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center