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Imaging
nCLE Aided Robotic Bronchoscopy for Lung Cancer (CLEAR Trial)
N/A
Recruiting
Research Sponsored by Johnson & Johnson Enterprise Innovation Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 22 years at signing of informed consent form (ICF)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post procedure
Awards & highlights
CLEAR Trial Summary
This trial is testing whether a new type of endoscopy, which uses a laser to get a more detailed view of the lungs, can improve the accuracy of biopsies performed with a robot.
Who is the study for?
This trial is for adults over 22 years old who need a lung nodule biopsy and are fit enough for bronchoscopy under anesthesia. They must not have bleeding disorders, be on certain blood thinners, or have devices like pacemakers that could interfere with the procedure. Pregnant or nursing women and those with known allergies to fluorescein sodium can't participate.Check my eligibility
What is being tested?
The study tests if using needle-based confocal laser endomicroscopy (nCLE) can make biopsies of lung nodules more accurate when done with robotic-assisted bronchoscopy (RANB) using the Monarch® Endoscopy Platform.See study design
What are the potential side effects?
Potential side effects may include discomfort from the biopsy procedure, risks associated with general anesthesia, allergic reactions to fluorescein sodium used in nCLE, and possible complications from bronchoscopy such as bleeding or infection.
CLEAR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
CLEAR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 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
'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.
Secondary outcome measures
Diagnostic yield
Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy
Safety of nCLE aided RANB biopsy procedure
+2 moreCLEAR Trial Design
1Treatment groups
Experimental Treatment
Group I: nCLE aided RANB biopsyExperimental Treatment1 Intervention
Single arm study
Find a Location
Who is running the clinical trial?
Johnson & Johnson Enterprise Innovation Inc.Lead Sponsor
2 Previous Clinical Trials
142 Total Patients Enrolled
Balaji Laxmanan, MDStudy DirectorJohnson & Johnson Enterprise Innovation Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to remove part of my lung during a bronchoscopy.I am currently pregnant or nursing.I am getting a biopsy for a lung nodule that may be cancerous.I cannot stop my blood thinning medication for surgery as per my doctor's advice.I am not fit for bronchoscopy under general anesthesia as per my doctor's assessment.You are allergic to fluorescein sodium or any ingredients in the product.I am 22 years old or older.You have a medical device like a pacemaker that can be affected by electronic navigation.My chest CT shows a lesion affecting my airways.
Research Study Groups:
This trial has the following groups:- Group 1: nCLE aided RANB biopsy
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 remaining openings for potential participants in this experimentation?
"Yes, the information on clinicialtrials.gov indicates that this trial is actively enrolling patients. The study was first uploaded on January 20th 2022 and has since been revised as of November 28th 2021."
Answered by AI
How many individuals are actively involved in this clinical experiment?
"That's right. According to the clinicaltrials.gov website, this research study is currently searching for participants. The post was originally published on January 20th 2022 and was last revised November 28th 2022. A total of 75 individuals will be accepted from two different sites."
Answered by AI
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