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

NCT05705544 | Completed Results DMC FDA Device

• 1 other identifier: 221255
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Pulmonary Lesions

Keywords

Electromagnetic navigational bronchoscopy; Shape-sensing catheter bronchoscopy; Diagnostic yield

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days post-enrollment

Secondary Outcomes (1)

• Duration of Procedure

  Duration of procedure, approximately 60 minutes

Study Arms (2)

ILLUMISITE™ Platform (EMN bronchoscopy)

ACTIVE COMPARATOR

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

Device: ILLUMISITE™ Platform (EMN bronchoscopy)

Ion™ Endoluminal System (SSCB bronchoscopy)

ACTIVE COMPARATOR

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)

Interventions

ILLUMISITE™ Platform (EMN bronchoscopy) DEVICE

Providers will utilize the ILLUMISITE™ Platform (EMN) machine to perform a diagnostic bronchoscopy procedure.

ILLUMISITE™ Platform (EMN bronchoscopy)

Ion™ Endoluminal System (SSCB bronchoscopy) DEVICE

Providers will utilize the Ion™ Endoluminal System (SSCB) machine to perform a diagnostic bronchoscopy procedure.

Ion™ Endoluminal System (SSCB bronchoscopy)

Eligibility Criteria

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

You may qualify if:

• years of age or older at time of bronchoscopy.
• Scheduled for navigational bronchoscopy for the evaluation of a peripheral pulmonary lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (12)

• 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

• Cicenia J, Avasarala SK, Gildea TR. Navigational bronchoscopy: a guide through history, current use, and developing technology. J Thorac Dis. 2020 Jun;12(6):3263-3271. doi: 10.21037/jtd-2019-ndt-11.

  PMID: 32642249 BACKGROUND

• Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, Murillo BA, LeMense GP, Minnich DJ, Bansal S, Ellis BQ, Mahajan AK, Gildea TR, Bechara RI, Sztejman E, Flandes J, Rickman OB, Benzaquen S, Hogarth DK, Linden PA, Wahidi MM, Mattingley JS, Hood KL, Lin H, Wolvers JJ, Khandhar SJ; NAVIGATE Study Investigators. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019 Mar;14(3):445-458. doi: 10.1016/j.jtho.2018.11.013. Epub 2018 Nov 23.

  PMID: 30476574 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

• 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

• Avasarala SK, Roller L, Katsis J, Chen H, Lentz RJ, Rickman OB, Maldonado F. Sight Unseen: Diagnostic Yield and Safety Outcomes of a Novel Multimodality Navigation Bronchoscopy Platform with Real-Time Target Acquisition. Respiration. 2022;101(2):166-173. doi: 10.1159/000518009. Epub 2021 Sep 3.

  PMID: 34515222 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

• 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

• 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

• Paez R, Lentz RJ, Duke JD, Siemann JK, Salmon C, Dahlberg GJ, Ratwani AP, Casey JD, Chen H, Chen SC, Shojaee S, Rickman OB, Gatto CL, Rice TW, Maldonado F. Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT). Am J Respir Crit Care Med. 2025 Sep;211(9):1644-1651. doi: 10.1164/rccm.202409-1846OC.

  PMID: 40460390 DERIVED

• Paez R, Lentz RJ, Salmon C, Siemann JK, Low SW, Casey JD, Chen H, Chen SC, Avasarala S, Shojaee S, Rickman OB, Lindsell CJ, Gatto CL, Rice TW, Maldonado F; Vanderbilt Learning Healthcare System Platform Investigators. Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial. Trials. 2024 Jan 19;25(1):66. doi: 10.1186/s13063-023-07863-3.

  PMID: 38243291 DERIVED

• Paez R, Lentz RJ, Salmon C, Siemann JK, Low SW, Casey JD, Chen H, Chen SC, Avasarala S, Shojaee S, Rickman OB, Lindsell CJ, Gatto CL, Rice TW, Maldonado F. Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial. Res Sq [Preprint]. 2023 Aug 28:rs.3.rs-3222369. doi: 10.21203/rs.3.rs-3222369/v1.

  PMID: 37693467 DERIVED

Related Links

• U.S. Food and Drug Administration. 510(K) Clearances. Accessed November 5, 2021

Results Point of Contact

• Title: Dr. Fabian Maldonado
• Organization: Vanderbilt University Medical Center

fabien.maldonado@vumc.org

(615) 322-5000

Study Officials

• Fabien Maldonado, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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, 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Thoracic Surgery, MD, MSc

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

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: March 6, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

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 5 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 (1)