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Needle Biopsy System
iNod™ Biopsy System for Pulmonary Nodules
N/A
Waitlist Available
Led By Alexander Chen, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post procedure
Awards & highlights
Study Summary
This trial tests the safety and accuracy of a medical device for finding and biopsying lung nodules and masses.
Who is the study for?
This trial is for adults with a solid lung lesion between 1-5 cm in size, who are able to follow study procedures and have agreed to undergo bronchoscopic evaluation. It's not for pregnant women, nursing mothers, those in conflicting studies without approval, or individuals with pure ground glass lesions or coagulopathy.Check my eligibility
What is being tested?
The iNod™ System is being tested for its safety and the ability to monitor the biopsy needle in real-time during procedures on endobronchial lesions and peripheral lung nodules or masses.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the biopsy site, bleeding, infection risk from the procedure, and potential complications related to any invasive diagnostic test.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 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
Adverse Events
Proportion of patients where the needle is visualized by the iNOD system inside the lesion
Other outcome measures
Biopsy Yield
Crossover Rate
Device Rotation
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: iNod™ SystemExperimental Treatment1 Intervention
Subjects with a qualifying lung lesion will have a standard of care Transbronchial Needle Aspiration using the the iNod™ System
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
718 Previous Clinical Trials
932,948 Total Patients Enrolled
Alexander Chen, MDPrincipal InvestigatorBarnes-Jewish Hospital
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had certain types of imaging procedures during the study.I am 18 years old or older.I have a mostly solid lung tumor between 1cm and 5cm, planning a bronchoscopy.My lung scan shows mostly non-solid spots.I am currently pregnant or breastfeeding.I cannot have certain lung exams due to health reasons, as decided by my doctor.A "peripheral" lesion in this study means any abnormal area in the lung that the doctor thinks cannot be reached using a specific type of bronchoscope.I have a known blood clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: iNod™ System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current availabilities for participants in this research study?
"Unfortunately, this clinical trial is not actively recruiting anymore. According to the information on clinicaltrials.gov, it was initially posted in September 1st 2023 and last updated on March 27th 2023; however, there are still 21 other trials looking for participants at this time."
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