Ion Endoluminal System for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the Ion Endoluminal System, a medical device, in everyday settings for locating or biopsying lung lesions (abnormal tissue). The focus is on its performance during real-world procedures. Individuals needing a planned lung lesion biopsy and able to follow study instructions may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the validation of a potentially groundbreaking medical device.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Ion Endoluminal System is safe for pulmonary lesion localization or biopsy?
Research has shown that the Ion Endoluminal System, used for lung biopsies, offers promising safety results. In one study, participants reported no serious health problems. This indicates that the system did not cause major issues for patients in that study. However, one patient experienced a pneumothorax, or collapsed lung, after a biopsy. Treatment involved a chest tube, a common method for managing this condition.
Overall, the Ion System is designed to be less invasive, typically resulting in fewer complications. However, as with any medical procedure, some risks remain.12345Why are researchers excited about this trial?
The Ion Endoluminal System is unique because it uses advanced robotic technology to navigate the intricate pathways of the lungs for biopsies. Unlike traditional methods, which often rely on manual bronchoscopy or CT-guided needle biopsies, this system offers a minimally invasive approach with precise targeting of pulmonary lesions. Researchers are excited about this technique because it promises to improve accuracy and safety, potentially reducing the need for more invasive procedures and enhancing patient outcomes.
What evidence suggests that the Ion Endoluminal System is effective for pulmonary lesion localization or biopsy?
Research has shown that the Ion Endoluminal System, which participants in this trial may experience, effectively takes tissue samples from lung nodules. One study found that it successfully collected useful samples in 83% of cases. Known for its accuracy, the system excels at reaching difficult lung areas. During operations, Ion accurately identified non-cancerous tissues, though its ability to detect cancer was moderate. Overall, the Ion system appears promising for improving lung nodule diagnosis.34678
Who Is on the Research Team?
Michael Pritchett, DO, MPH
Principal Investigator
FirstHealth of the Carolinas
Janani Reisenauer, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Ion Endoluminal System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Intuitive Surgical
Lead Sponsor
Gary Guthart
Intuitive Surgical
Chief Executive Officer since 2010
PhD in Engineering, California Institute of Technology
Henry Charlton
Intuitive Surgical
Chief Medical Officer since 2023
MD from an unspecified institution
Citations
Latest Research on Ion Robotic Bronchoscopy
Examining outcomes data helps generate evidence showing the potential role of Ion endoluminal systems in the patient journey for lung nodule biopsy. Several ...
Accuracy and efficacy of Ion robotic-assisted ...
Intraoperative diagnoses performed on fine needle aspirations acquired using Ion were highly specific but showed moderate sensitivity in diagnosing malignancy.
3.
investor.intuitivesurgical.com
investor.intuitivesurgical.com/news-releases/news-release-details/precise-clinical-study-preliminary-results-favorable-intuitivesPRECIsE Clinical Study Preliminary Results Favorable for ...
Use of the Ion system for pulmonary nodule biopsy resulted in an 83% diagnostic yield, which represents the likelihood that tissue samples obtained during the ...
Shape-sensing robotic-assisted bronchoscopy for ...
Such reports highlight the need for improved procedural outcomes for small peripheral nodules by developing new bronchoscopy tools and ...
Study Details | NCT05160571 | A Retrospective Multicenter ...
This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion ...
Ion Robotic Bronchoscopy
We built Ion on the belief that collecting lung tissue samples for biopsy could be safe and simple, even when lung nodules are small and located in the ...
7.
accessdata.fda.gov
accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=17659845&pc=EOQMAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION
It was reported that the patient underwent an ion endoluminal lung biopsy procedure and developed a pneumothorax requiring a chest tube.
8.
pennmedicine.org
pennmedicine.org/physicians-hub/physician-article/ion-robotic-lung-biopsy-system-shortens-lung-cancer-diagnosis-journeyIon robotic biopsy system abbreviates lung cancer diagnosis
The Ion robotic bronchoscopy system's thin, maneuverable catheter allows clinicians to reach small lesions in all 18 segments of the lung.
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