An interventional study of RAB via the Monarch platform and RAB via the ION platform in Lung; Node, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
This is an investigator-initiated cluster randomized control trial. The primary objective is to compare the diagnostic yield of two Food and Drug Administration (FDA) cleared national robotic assisted bronchoscopy platforms - the Monarch™ Platform and the ION™ Endoluminal System - in participants undergoing bronchoscopy to evaluate peripheral pulmonary lesions (PPLs). Participants will undergo their scheduled robotic assisted bronchoscopy (RAB) using one of these platforms.
Roughly 1.6 million lung nodules are identified every year in the United States. When tissue sampling is required, robotic-assisted bronchoscopy (RAB) systems are increasingly used to reach peripheral targets inaccessible to standard bronchoscopy.
Robotic-assisted bronchoscopy (RAB) has rapidly evolved as a promising modality for sampling PPLs. Two FDA-cleared robotic platforms are currently in clinical use: the ION™ Endoluminal System (Intuitive Surgical, Inc., Sunnyvale, CA) and the Monarch™ Platform (Johnson \& Johnson MedTech / Auris Health, Redwood City, CA). Both platforms were cleared through the FDA 510(k) pathway, which requires demonstration of substantial equivalence to predicate devices but does not mandate comparative effectiveness data prior to commercialization.
The ION™ system uses shape-sensing fiber-optic technology to track catheter position with high precision throughout the bronchial tree. It has been shown in multiple studies to achieve diagnostic yields ranging from 67-85%, with enhanced performance when combined with intraprocedural cone-beam computed tomography (CBCT). The recent RELIANT trial (the first cluster-randomized controlled trial in interventional pulmonology) demonstrated that ION™ was non-inferior to electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis, with diagnostic yields of 77.8% and 75.5% respectively (P for non-inferiority = 0.007).
The Monarch™ platform uses a hybrid approach combining electromagnetic tracking and robotic catheter control with a continuously visualizing bronchoscope (4-way articulation). A key feature of the Monarch™ is direct bronchoscopic vision throughout navigation, enabling real-time assessment of the airways and the target lesion. The Monarch™ has received additional FDA clearance for bronchoscopic transparenchymal nodule access (BTPNA), allowing access to lesions without a direct airway path. Published studies report diagnostic yields of 66-81% for the Monarch™ platform, though most are single-center, non-randomized studies with varying definitions of diagnostic yield, co-intervention use, and did not fully use integrated intraprocedural imaging (including fluoroscopy and CBCT, as available and integrated).
Critically, no randomized or high-quality comparative study has directly compared the ION™ and Monarch™ platforms head-to-head with integrated intraprocedural imaging. As both systems are now available at University Hospitals Cleveland Medical Center and represent substantial capital expenditures, high-quality prospective comparative data are urgently needed to guide clinical decision-making and resource allocation. This trial leverages the existing dual-platform clinical infrastructure at UHCMC to conduct a pragmatic, cluster-randomized, non-inferiority trial embedded within routine clinical care
Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is being conducted at a hospital that has two bronchoscopy procedure rooms (BPRs). The unit of the randomization is the BPR day. Each day, one BPR will be randomized to the Monarch platform and the other to the ION platform. Participants in this arm will have undergone their RAB via the Monarch platform.
Procedure: RAB via the Monarch platform
This study is being conducted at a hospital that has two bronchoscopy procedure rooms (BPRs). The unit of the randomization is the BPR day. Each day, one BPR will be randomized to the Monarch platform and the other to the ION platform. Participants in this arm will have undergone their RAB via the ION platform.
Procedure: RAB via the ION platform
The Monarch™ (Monarch) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses a hybrid approach combining electromagnetic tracking and robotic catheter control with a continuously visualizing bronchoscope (4-way articulation). A key feature of the Monarch platform is direct bronchoscopic vision throughout navigation, enabling real-time assessment of the airways and the target lesion.
Also known as: Monarch™
The ION™ Endoluminal System (ION) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses shape-sensing fiber-optic technology to track catheter position with high precision throughout the bronchial tree.
Also known as: ION™ Endoluminal System
Diagnostic yield defined as the proportion of procedures that result in the acquisition of lesional tissue
Diagnostic yield is defined as the proportion of procedures that result in the acquisition of lesional tissue. This will be measured for both procedures conducted via the Monarch platform and the ION platform.
Time frame: Up to Day 14
Duration of the robotic bronchoscopy procedures
The duration of the robotic bronchoscopy procedure will be measured in minutes for both the Monarch platform and the ION platform.
Time frame: Day 0
Safety, measured by the number of complications
Safety will be measured by the number of complications that occur within 7 days of the procedure for both the Monarch platform group and the ION platform group.
Time frame: Up to Day 7
Radiation exposure
Radiation exposure is defined as the radiation dose delivered to the participant during the study bronchoscopy and is recorded as a dose area product in milligray per centimeters squared (mGy/cm2). Radiation exposure is measured for both the Monarch platform group and the ION platform group.
Time frame: Day 0
Rate of additional diagnostic procedures required within 12 months
The rate of additional diagnostic procedures required within 12 months of the study bronchoscopy will be assess for both the Monarch platform group and the ION group.
Time frame: Up to 12 months
Diagnostic accuracy at 12 months post-biopsy
Diagnostic accuracy at 12 months post-biopsy is defined as the number of true positive lesions (malignant) plus true negative lesions (specific benign diagnosis) with no evidence of malignancy at 12-month follow-up (no interval biopsy diagnostic of malignancy, regression on CT or stable size with no plan for repeat diagnostic procedure), divided by the total number of biopsied lesions. This will be assessed for both the Monarch platform group and the ION platform group.
Time frame: Up to 12 months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
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 University Hospitals Institutional Review Board and the study executive committee.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet 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.
Case Comprehensive Cancer Center →