Lung; NodeNCT07735611
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
A study testing RAB via the Monarch platform and RAB via the ION platform in people with Lung; Node, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Node
- What is being tested?
- RAB via the Monarch platform and RAB via the ION platform
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of bronchoscopy.
- Scheduled to undergo navigational bronchoscopy (either ION™ or Monarch™) for the evaluation of a pulmonary lesion at University Hospitals Cleveland Medical Center (UHCMC).
- Able and willing to provide written informed consent.
Who cannot join
- Enrolled in another clinical trial that requires the use of a specific navigational/robotic bronchoscopy platform.
- Enrolled in another bronchoscopy-related clinical trial.
- Participant or legally authorized representative declines participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Sameer K Avasarala, MD, Sameer.Avasarala@uhhospitals.org
Sameer K Avasarala, MD
About this study
Official title: Robotic Systems Evaluation for Peripheral Pulmonary Lesions: A Randomized Trial (RISE Trial)
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.
Read the detailed description
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
- Conditions
- Lung; Node
- Being tested
- RAB via the Monarch platform, RAB via the ION platform
- Keywords
- Bronchoscopy, Robotic assisted bronchoscopy, Monarch™, ION™ Endoluminal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAB via the Monarch platformProcedure or surgery
Also called Monarch™
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.
RAB via the ION platformProcedure or surgery
Also called ION™ Endoluminal System
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.
| Study group | Role | What they receive |
|---|---|---|
| Monarch Platform | Other | 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. Receives: Procedure: RAB via the Monarch platform |
| ION Platform | Other | 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. Receives: Procedure: RAB via the ION platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 14
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is being conducted at University Hospitals, where there are two bronchoscopy procedure rooms (BPR). The unit of randomization is the BPR day. Each BPR day constitutes one cluster. The robotic bronchoscopy platform assigned to each BPR each day is determined by random allocation each morning via sealed, opaque, day-of-week-stratified envelopes prepared by a biostatistician not involved in clinical care or participant scheduling.
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameer K Avasarala, MD, Principal investigator, Case Comprehensive Cancer Center, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735611
- Sponsor's protocol ID
- CASE3526
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Systems Evaluation for Peripheral Pulmonary Lesions: A Randomized Trial (RISE Trial)
- ClinicalTrials.gov ID
- NCT07735611
- Acronym / sponsor ID
- CASE3526
- Conditions
- Lung; Node
- Keywords
- Bronchoscopy, Robotic assisted bronchoscopy, Monarch™, ION™ Endoluminal System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is being conducted at University Hospitals, where there are two bronchoscopy procedure rooms (BPR). The unit of randomization is the BPR day. Each BPR day constitutes one cluster. The robotic bronchoscopy platform assigned to each BPR each day is determined by random allocation each morning via sealed, opaque, day-of-week-stratified envelopes prepared by a biostatistician not involved in clinical care or participant scheduling.
| Arm | Type | Receives |
|---|---|---|
| Monarch Platform | Other | Procedure: RAB via the Monarch platformThis 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. |
| ION Platform | Other | Procedure: RAB via the ION platformThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years at the time of bronchoscopy.
- Scheduled to undergo navigational bronchoscopy (either ION™ or Monarch™) for the evaluation of a pulmonary lesion at University Hospitals Cleveland Medical Center (UHCMC).
- Able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Enrolled in another clinical trial that requires the use of a specific navigational/robotic bronchoscopy platform.
- Enrolled in another bronchoscopy-related clinical trial.
- Participant or legally authorized representative declines participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAB via the Monarch platformAlso: Monarch™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. | Procedure or surgery | Monarch Platform |
| RAB via the ION platformAlso: ION™ Endoluminal SystemThe 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. | Procedure or surgery | ION Platform |
Primary outcome
Diagnostic yield defined as the proportion of procedures that result in the acquisition of lesional tissue
Time frame: Up to Day 14
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.
5 secondary outcomes
Duration of the robotic bronchoscopy procedures
Time frame: Day 0
Safety, measured by the number of complications
Time frame: Up to Day 7
Radiation exposure
Time frame: Day 0
Rate of additional diagnostic procedures required within 12 months
Time frame: Up to 12 months
Diagnostic accuracy at 12 months post-biopsy
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sameer K Avasarala, MD principal investigator
Case Comprehensive Cancer Center, University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAB via the Monarch platform and RAB via the ION platform in people with Lung; Node, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameer K Avasarala, MD (216-844-3201, Sameer.Avasarala@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield defined as the proportion of procedures that result in the acquisition of lesional tissue (time frame: Up to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.