Robotic Systems for Lung Nodules
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of two robotic systems, the Monarch™ Platform and the ION™ Endoluminal System, in diagnosing lung nodules. Lung nodules are small tissue masses in the lungs that can be benign or malignant. Participants will undergo bronchoscopy, a procedure to examine the lungs, using one of these robotic systems. The trial seeks participants with a scheduled bronchoscopy at University Hospitals Cleveland Medical Center to assess a lung lesion. As an unphased trial, this study provides participants the chance to contribute to advancements in medical technology for lung diagnostics.
What prior data suggests that these robotic systems are safe for evaluating lung nodules?
Previous studies have shown the Monarch™ Platform to be safe. In one study, a small number of patients (3.7%) experienced a collapsed lung, and only 1.9% required a chest tube. This rate aligns with that of regular bronchoscopy, a procedure used to examine the lungs.
The ION™ Endoluminal System also yielded positive results. Research indicates that only 0.6% of procedures resulted in a collapsed lung, with no reports of bleeding. This suggests the procedure is safe and well-tolerated by most patients.
Overall, both robotic systems are considered safe options for diagnosing lung nodules. They maintain safety records similar to traditional methods while offering the advantage of being less invasive.12345Why are researchers excited about this trial?
Researchers are excited about this trial because the ION™ Endoluminal System and Monarch™ Platform bring innovative robotic technology to lung nodule procedures, potentially enhancing precision and safety. Unlike traditional bronchoscopy, these robotic systems offer improved reach and stability, which may lead to more accurate targeting of lung nodules. This could mean earlier and more effective diagnosis for patients with suspicious lung nodules, providing a significant advantage over conventional methods.
What evidence suggests that these robotic systems are effective for evaluating lung nodules?
This trial will compare the Monarch™ Platform and the ION™ Endoluminal System for diagnosing lung nodules. Research has shown that the Monarch™ Platform successfully identifies and samples lung nodules located outside a patient's airway in about 70–77% of cases, with a navigation success rate of 88.6%. In contrast, the ION™ Endoluminal System, used in another arm of this trial, identifies lung nodules in 82–86.9% of cases and achieves 99% accuracy in placing biopsy tools directly into the nodules. Both systems aim to improve the accuracy of diagnosing lung nodules, which is crucial for early detection and treatment.46789
Who Is on the Research Team?
Sameer K Avasarala, MD
Principal Investigator
Case Comprehensive Cancer Center, University Hospitals
Are You a Good Fit for This Trial?
This trial is for people who have lung nodules and are scheduled to undergo a robotic-assisted bronchoscopy to check these spots. Participants must be eligible for this procedure, but specific inclusion or exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo robotic-assisted bronchoscopy using either the Monarch or ION platform
Follow-up
Participants are monitored for safety and effectiveness after the bronchoscopy procedure
What Are the Treatments Tested in This Trial?
Interventions
- ION™ Endoluminal System
- Monarch™ Platform
Trial Overview
The study compares two FDA-approved robotic systems—Monarch and ION—for performing bronchoscopies on lung nodules. Patients will be randomly assigned to one of the two platforms during their scheduled procedure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
Citations
Shape-Sensing Robotic Assisted Bronchoscopy for Biopsy of ...
Primary outcome is rate of tool-in-nodule (TIN) confirmed via intraprocedural 3-D imaging with CIOS Spin. Secondary outcomes are procedural characteristics, ...
2.
surgicalroboticstechnology.com
surgicalroboticstechnology.com/news/intuitive-announces-favorable-preliminary-results-for-ion-in-precise-clinical-study/Intuitive Announces Favorable Preliminary Results for ION ...
Encouraging diagnostic yield for both smaller and larger nodules: Ion-enabled biopsies helped investigators obtain a diagnosis in 82% of cases ...
3.
intelligenthealth.tech
intelligenthealth.tech/2025/12/16/ion-robotic-assisted-bronchoscopy-could-enable-early-lung-cancer-diagnosis-uk-first-study-finds/Ion robotic-assisted bronchoscopy could enable early lung ...
Published in Thorax, the study reported: Ninety-nine percent tool in lesion rate (198/200 patients), meaning physicians precisely placed a biopsy tool within ...
4.
sciaccessjournals.org
sciaccessjournals.org/articles/review-technology-and-techniques-for-robotic-assisted-bronchoscopy.htmlReview: Technology and Techniques for Robotic-assisted ...
The 5-year survival of patients with metastatic cancer at diagnosis is only 6.3%, making early detection and diagnosis of pulmonary nodules critical3 With ...
Assessment of Diagnostic Yield Using a Robotic Navigational ...
The aim of this research study is to evaluate the effectiveness of the ION endoluminal system at reaching and obtaining biopsies from lung nodules when used in ...
6.
scholarlycommons.henryford.com
scholarlycommons.henryford.com/cgi/viewcontent.cgi?article=1131&context=pulmonary_articlesinitial multicenter experience using the Ion™ Endoluminal S
Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported. reported incidence of pneumotho- rax or bleeding
7.
humanforschung-schweiz.ch
humanforschung-schweiz.ch/de/studiensuche/studien-detail/67144/translate/en/?cHash=1eb14153126abd62db672c88a1869faeObservational Study to Evaluate Real-World Outcomes for the ...
The purpose of this study is to collect data to understand how accurately medical professionals utilize the Ion Endoluminal System, imaging (e.g., CT scan), and ...
Ion Robotic Bronchoscopy Is a Safe, Effective Modality for ...
Ion robotic bronchoscopy is a safe and effective modality to manage lung nodules, with a pneumothorax rate of 0.6% and a diagnostic yield of 90 ...
Shape-Sensing Robotic-Assisted Bronchoscopy in the ...
Shape-sensing robotic-assisted bronchoscopy allowed successful navigation in 98.7% and diagnostic sampling in 81.7% of lesions, with an overall complication ...
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