← Back to Search

Needle

Needle Size Impact on EBUS-TBNA for Sarcoidosis and Lymphoma

N/A
Recruiting
Led By Thomas Vandemoortele, MD, MSc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient investigated in the setting of either an initial diagnosis or a suspicion of lymphoma recurrence (post-treatment).
Patient referred for specimens by EBUS-TBNA with clinical and radiological suspicion of sarcoidosis or lymphoma, with pathological lymph node on imaging (small diameter ≥ 1.0 cm CT-scan or hyper metabolism with PET scan) in para-tracheal stations, sub-carinal and/or hilar (stations 2, 4, 7, 10, 11 and 12), right and/or left.
Must not have
Obvious involvement of organ(s) with the possibility of confirming granulomas or suspicious cells of lymphoma by means of a procedure considered less invasive (e.g., lymph node biopsy of cervical, supraclavicular or inguinal nodes; skin biopsy).
Patient unable to give consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after enrollment of last patient.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the diagnostic yield of a new 19G needle with the standard 22G needle for the investigation of sarcoidosis & lymphoma in the lungs.

Who is the study for?
This trial is for adults with suspected or recurring lymphoma, or sarcoidosis, evidenced by enlarged lymph nodes on imaging. Participants must be able to consent and tolerate the procedure. It excludes pregnant women, minors, those unable to consent, patients with significant coagulopathy or on non-suspendable anticoagulation therapy.
What is being tested?
The study compares two needle sizes for EBUS-TBNA (a minimally invasive test using ultrasound-guided needles) in diagnosing sarcoidosis and lymphoma: a larger flexible 19G needle versus the standard smaller 22G needle.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, minor bleeding due to needle insertion, risk of infection post-procedure and very rarely damage to surrounding structures during the biopsy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am being tested for lymphoma for the first time or for a possible recurrence.
Select...
I am referred for a test due to suspected sarcoidosis or lymphoma, with certain lymph nodes appearing abnormal on scans.
Select...
I am referred for a biopsy due to suspected sarcoidosis or lymphoma, with abnormal lymph nodes detected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition may be confirmed with a less invasive procedure like a lymph node or skin biopsy.
Select...
I am unable to give consent for medical procedures.
Select...
I am currently pregnant.
Select...
I am younger than 18 years old.
Select...
I am on blood thinners that cannot be stopped for a procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after enrollment of last patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after enrollment of last patient for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic yield of EBUS-TBNA
Secondary study objectives
Complications
Ease of use.
Specimen quality

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vizishot Flexneedle 19GExperimental Treatment1 Intervention
Mediastinal and hilar lymph node sampling using the Vizishot Flexneedle19G EBUS-TBNA needle
Group II: Vizishot 22GActive Control1 Intervention
Mediastinal and hilar lymph node sampling using a standard Vizishot 22G EBUS-TBNA needle

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
380 Previous Clinical Trials
131,539 Total Patients Enrolled
Thomas Vandemoortele, MD, MScPrincipal InvestigatorCHUM

Media Library

ViziShot FLEX 19G needle (Needle) Clinical Trial Eligibility Overview. Trial Name: NCT03573362 — N/A
Sarcoidosis Research Study Groups: Vizishot 22G, Vizishot Flexneedle 19G
Sarcoidosis Clinical Trial 2023: ViziShot FLEX 19G needle Highlights & Side Effects. Trial Name: NCT03573362 — N/A
ViziShot FLEX 19G needle (Needle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03573362 — N/A
~0 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top