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Procedure

nCLE arm for Lung Cancer (CLEVER Trial)

N/A

Recruiting

Led By Jouke Annema, Prof. dr.

Research Sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after all patients have been included (expected total time frame 2 years)

Awards & highlights

CLEVER Trial Summary

This trial is trying to determine if using a needle-based imaging technique called confocal laser endomicroscopy (nCLE) during a bronchoscopy procedure can improve the accuracy of diagnosing lung nod

Who is the study for?

This trial is for adults over 18 with suspected malignant lung lesions suitable for bronchoscopic diagnosis. The lesion must be solid, larger than 10mm but not exceeding 30mm, and accessible by conventional bronchoscopy as indicated by a CT scan. Participants must understand and consent to the study.Check my eligibility

What is being tested?

The trial tests if adding needle-based confocal laser endomicroscopy (nCLE) to regular diagnostic bronchoscopy improves the chances of correctly diagnosing lung cancer in patients with peripheral pulmonary nodules.See study design

What are the potential side effects?

While specific side effects are not listed, nCLE involves imaging during bronchoscopy which may increase procedure time and could potentially lead to complications related to longer bronchoscopies such as discomfort or infection.

CLEVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am suspected to have lung cancer and need a lung biopsy.

CLEVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after all patients have been included (expected total time frame 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after all patients have been included (expected total time frame 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after all patients have been included (expected total time frame 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic yield (intermediate definition)

Secondary outcome measures

Additional diagnostics needed

Complication rate

Diagnostic sensitivity

+10 more

CLEVER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: nCLE armExperimental Treatment2 Interventions

Diagnostic bronchoscopy is done according to institutional practice with the addition of nCLE

Group II: Control armActive Control1 Intervention

Diagnostic bronchoscopy is done according to institutional practice without the addition of nCLE

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mauna Kea TechnologiesIndustry Sponsor

19 Previous Clinical Trials

1,604 Total Patients Enrolled

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)Lead Sponsor

9 Previous Clinical Trials

6,326 Total Patients Enrolled

Jouke Annema, Prof. dr.Principal InvestigatorAmsterdam UMC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different venues is this experimental investigation currently being supervised?

"At present, this clinical trial is actively enrolling patients from a total of 7 sites. These sites are situated in various cities including Prague, Vienna, Winterthur, and other locations as well. To reduce travel constraints for participating individuals, it would be advantageous to select the site closest to your location."

Answered by AI

Is the enrollment of participants currently ongoing for this research study?

"Indeed, the details provided on clinicaltrials.gov indicate that this ongoing trial is actively seeking individuals to participate. Initially posted on October 18th, 2023, it was last updated on January 17th, 2024. The study aims to enroll a total of 208 participants distributed across seven different sites."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on October 18th, 2023 and received its most recent update on January 17th, 2024. In total, the trial aims to enroll a cohort of 208 patients across seven different medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Confocal Laser Endomicroscopy VERification

Prof. dr. J.T. Annema 2023. "Confocal Laser Endomicroscopy VERification". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079970.

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