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Endoscopy Device
Robotic Bronchoscopy for Lung Cancer
N/A
Waitlist Available
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months post-procedure
Awards & highlights
Study Summary
This trial will help researchers figure out if the Ion system is a helpful tool for taking samples from pulmonary nodules.
Who is the study for?
This trial is for adults who may have lung cancer or lung disease, with nodules in their lungs that are between 1 and 3 cm big. They should be fit for a bronchoscopy, which is a look inside the airways using a special camera. People can join if they're at moderate to high risk of having lung cancer or might have cancer spread to their lungs from elsewhere.Check my eligibility
What is being tested?
The Ion Endoluminal System™ is being tested in this study. It's a tool used during bronchoscopy to reach and get samples from small growths (nodules) in the lungs that could be cancerous. The goal is to see how well it works and how useful it is in these procedures.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of bronchoscopic procedures include discomfort in the throat, coughing, infection risk, bleeding where tissue was taken for testing, and rarely more serious complications like collapsed lung.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biopsy Success
Navigation Success
Sensitivity for Malignancy of System-Obtained Sample
Secondary outcome measures
Complications
Trial Design
1Treatment groups
Experimental Treatment
Group I: Robotic BronchoscopyExperimental Treatment1 Intervention
The Ion™ Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
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Who is running the clinical trial?
Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
48,894 Total Patients Enrolled
Erik Folch, MDStudy ChairMassachusetts General Hospital
1 Previous Clinical Trials
1,388 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research undertaking still available?
"As confirmed on clinicaltrials.gov, the recruitment period for this medical trial has ended as of September 14th 2022. Originally published on March 29 2019, it is no longer seeking patients; however there are 696 other trials actively recruiting at present."
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