Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging

NCT06654271 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 241103
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 4

Brief Summary

RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.

Conditions

Peripheral Pulmonary Lesion; Lung Nodule, Solitary

Keywords

Electromagnetic navigation bronchoscopy; Robotic assisted bronchoscopy; Cone beam computed tomography; Diagnostic yield

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.

  Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: * Malignancy * Specific benign pathologic findings including: * Organizing pneumonia * Frank purulence/robust neutrophilic inflammation * Granulomatous inflammation * Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist.

  7 days post-procedure

Secondary Outcomes (1)

• Duration of bronchoscopy (in minutes)

  Duration of procedure, approximately 60 minutes

Study Arms (2)

Robotic assisted bronchoscopy (RAB)

ACTIVE COMPARATOR

Robotic assisted bronchoscopy with integrated cone beam computed tomography

Device: Robotic assisted bronchoscopy (RAB)

Electromagnetic navigation bronchoscopy (ENB)

ACTIVE COMPARATOR

Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis

Device: Electromagnetic navigation bronchoscopy (ENB)

Interventions

Robotic assisted bronchoscopy (RAB) DEVICE

Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography

Robotic assisted bronchoscopy (RAB)

Electromagnetic navigation bronchoscopy (ENB) DEVICE

Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis

Electromagnetic navigation bronchoscopy (ENB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at time of bronchoscopy
• Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion

You may not qualify if:

• Patient declines to participate
• Patients enrolled in another trial which requires the use of one specific navigational platform

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (12)

• Zhang C, Xie F, Li R, Cui N, Herth FJF, Sun J. Robotic-assisted bronchoscopy for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Thorac Cancer. 2024 Mar;15(7):505-512. doi: 10.1111/1759-7714.15229. Epub 2024 Jan 29.

  PMID: 38286133 BACKGROUND

• Kalchiem-Dekel O, Connolly JG, Lin IH, Husta BC, Adusumilli PS, Beattie JA, Buonocore DJ, Dycoco J, Fuentes P, Jones DR, Lee RP, Park BJ, Rocco G, Chawla M, Bott MJ. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis of Pulmonary Parenchymal Lesions. Chest. 2022 Feb;161(2):572-582. doi: 10.1016/j.chest.2021.07.2169. Epub 2021 Aug 9.

  PMID: 34384789 BACKGROUND

• Low SW, Lentz RJ, Chen H, Katsis J, Aboudara MC, Whatley S, Paez R, Rickman OB, Maldonado F. Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance. Chest. 2023 Apr;163(4):977-984. doi: 10.1016/j.chest.2022.10.019. Epub 2022 Oct 29.

  PMID: 36441041 BACKGROUND

• Katsis J, Roller L, Aboudara M, Pannu J, Chen H, Johnson J, Lentz RJ, Rickman O, Maldonado F. Diagnostic Yield of Digital Tomosynthesis-assisted Navigational Bronchoscopy for Indeterminate Lung Nodules. J Bronchology Interv Pulmonol. 2021 Oct 1;28(4):255-261. doi: 10.1097/LBR.0000000000000766.

  PMID: 33734149 BACKGROUND

• Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.

  PMID: 26214244 BACKGROUND

• Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023 Jun;163(6):1589-1598. doi: 10.1016/j.chest.2022.12.044. Epub 2023 Jan 11.

  PMID: 36640994 BACKGROUND

• Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, Shah PL, Slebos DJ, Valipour A, Wahidi MM, Weir M, Herth FJ. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020 Jul 1;202(1):29-50. doi: 10.1164/rccm.201907-1292SO.

  PMID: 32023078 BACKGROUND

• Agrawal A, Hogarth DK, Murgu S. Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data. J Thorac Dis. 2020 Jun;12(6):3279-3286. doi: 10.21037/jtd.2020.03.35.

  PMID: 32642251 BACKGROUND

• Aboudara M, Roller L, Rickman O, Lentz RJ, Pannu J, Chen H, Maldonado F. Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2020 Feb;25(2):206-213. doi: 10.1111/resp.13609. Epub 2019 Jul 2.

  PMID: 31265204 BACKGROUND

• Styrvoky K, Schwalk A, Pham D, Madsen K, Chiu HT, Abu-Hijleh M. Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study. J Thorac Dis. 2023 Sep 28;15(9):4836-4848. doi: 10.21037/jtd-23-587. Epub 2023 Aug 30.

  PMID: 37868864 BACKGROUND

• Paez R, Ratwani AP, Duke JD, Bridwell G, Leonard K, Katsis JM, Pickering EM, Thiboutot J, Chen H, Chen SC, Shojaee S, Yarmus L, Lentz RJ, Maldonado F; Interventional Pulmonary Outcomes Group. Robotic versus electromagnetic bronchoscopy for pulmonary leslon assessment using integrated intraprocedural imaging: Study protocol for the reliant 2 trial. PLoS One. 2025 Dec 3;20(12):e0327611. doi: 10.1371/journal.pone.0327611. eCollection 2025.

  PMID: 41336287 DERIVED

• Chen SC, Chen H, Paez R, Gatto CL, Lentz RJ, Maldonado F. A randomization strategy for a cluster-randomized controlled trial with variable operating room availability. Contemp Clin Trials. 2025 Oct;157:108057. doi: 10.1016/j.cct.2025.108057. Epub 2025 Aug 28.

  PMID: 40885487 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rafael Paez, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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, allocation will be concealed until the morning of the procedure. Thoracic pathologists and bronchoscopy schedulers will remain blinded, thus allocations will not influence scheduling of procedures or histopathological interpretation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: November 11, 2024
• Primary Completion: October 14, 2025
• Study Completion (Estimated): October 14, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (4)