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nCLE Aided Robotic Bronchoscopy for Lung Cancer (CLEAR Trial)

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
Undergoing standard-of-care RANB for a solid lung nodule, which is considered to be at intermediate- to high-risk for malignancy as determined by the investigator per the institution's standard of care
Age ≥ 22 years at signing of informed consent form (ICF)
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post procedure
Awards & highlights
No Placebo-Only Group

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 below
I am getting a biopsy for a lung nodule that may be cancerous.
I am 22 years old or older.

CLEAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post procedure for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

CLEAR 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
1 Previous Clinical Trials
76 Total Patients Enrolled
Balaji Laxmanan, MDStudy DirectorJohnson & Johnson Enterprise Innovation Inc.

Media Library

nCLE aided RANB biopsy (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05231278 — N/A
Lung Cancer Research Study Groups: nCLE aided RANB biopsy
Lung Cancer Clinical Trial 2023: nCLE aided RANB biopsy Highlights & Side Effects. Trial Name: NCT05231278 — N/A
nCLE aided RANB biopsy (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231278 — N/A

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
~24 spots leftby Feb 2025