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NCT05705544: RELIANT

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

Completed NA Results posted Last updated 24 April 2025
What this trial tests

NA trial testing ILLUMISITE™ Platform (EMN bronchoscopy) in Peripheral Pulmonary Lesions in 447 participants. Completed in 9 April 2024.

Timeline
6 March 2023
Primary endpoint
9 April 2024
9 April 2024

Quick facts

Lead sponsorVanderbilt University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposediagnostic
Enrollment447
Start date6 March 2023
Primary completion9 April 2024
Estimated completion9 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Peripheral Pulmonary Lesions. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Yield Primary · 7 days post-enrollment

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

GroupValue95% CI
ILLUMISITE™ Platform (EMN Bronchoscopy)157
Ion™ Endoluminal System (SSCB Bronchoscopy)158
Duration of Procedure Secondary · Duration of procedure, approximately 60 minutes

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

GroupValue95% CI
ILLUMISITE™ Platform (EMN Bronchoscopy)32.025.0 – 43.3
Ion™ Endoluminal System (SSCB Bronchoscopy)37.029.0 – 48.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ILLUMISITE™ Platform (EMN Bronchoscopy)
Serious: 7/208 (3%)
Deaths: 0/208
Ion™ Endoluminal System (SSCB Bronchoscopy)
Serious: 5/203 (2%)
Deaths: 0/203

Serious adverse events (2 terms)

ReactionSystemILLUMISITE™ Platform (EMN …Ion™ Endoluminal System (S…
PneumothoraxRespiratory, thoracic and mediastinal disorders
Anesthesia ComplicationInjury, poisoning and procedural complications
Other adverse events (4 terms — click to expand)

ReactionSystemILLUMISITE™ Platform (EMN …Ion™ Endoluminal System (S…
Persistent dyspnea post-procedureRespiratory, thoracic and mediastinal disorders
HypoxiaRespiratory, thoracic and mediastinal disorders
COPD ExacerbationRespiratory, thoracic and mediastinal disorders
Persistent CoughRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Pneumothorax, Anesthesia Complication.

Data from ClinicalTrials.gov NCT05705544 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.
    Paez R, Lentz RJ, Salmon C, Siemann JK, et al · · 2024 · cited 15× · PMID 38243291 · DOI 10.1186/s13063-023-07863-3
  2. Real-World Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.
    Ortiz-Jaimes G, Reisenauer J. · · 2023 · cited 9× · PMID 37694262 · DOI 10.2147/por.s395806
  3. Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT).
    Paez R, Lentz RJ, Duke JD, Siemann JK, et al · · 2025 · cited 8× · PMID 40460390 · DOI 10.1164/rccm.202409-1846oc
  4. Digital Tomosynthesis: Review of Current Literature and Its Impact on Diagnostic Bronchoscopy.
    Jain A, Sarkar A, Husnain SMN, Adkinson BC, et al · · 2023 · cited 6× · PMID 37568943 · DOI 10.3390/diagnostics13152580
  5. Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial.
    Paez R, Ratwani AP, Duke JD, Bridwell G, et al · · 2025 · PMID 41336287 · DOI 10.1371/journal.pone.0327611
  6. A randomization strategy for a cluster-randomized controlled trial with variable operating room availability.
    Chen SC, Chen H, Paez R, Gatto CL, et al · · 2025 · PMID 40885487 · DOI 10.1016/j.cct.2025.108057
  7. Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT using integrated intraprocedural imaging: study protocol for the RELIANT 2 trial
    Paez R, Ratwani AP, Duke JD, Bridwell G, et al · · 2025 · DOI 10.1101/2025.06.19.25329969
  8. Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.
    Paez R, Lentz RJ, Salmon C, Siemann JK, et al · · 2023 · DOI 10.21203/rs.3.rs-3222369/v1

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