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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after enrollment of last patient
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week after enrollment of last patient.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after enrollment of last patient.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic yield of EBUS-TBNA
Secondary outcome measures
Complications
Ease of use.
Specimen quality
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
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
Thomas Vandemoortele, MD, MScPrincipal InvestigatorCHUM
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition may be confirmed with a less invasive procedure like a lymph node or skin biopsy.I am unable to give consent for medical procedures.I am currently pregnant.I am being tested for lymphoma for the first time or for a possible recurrence.I am younger than 18 years old.I am referred for a test due to suspected sarcoidosis or lymphoma, with certain lymph nodes appearing abnormal on scans.My scans show lymph nodes larger than 0.5 cm.I can sign the consent form and allow access to my medical results.I am considered healthy enough for the procedure.I am on blood thinners that cannot be stopped for a procedure.I am referred for a biopsy due to suspected sarcoidosis or lymphoma, with abnormal lymph nodes detected.
Research Study Groups:
This trial has the following groups:- Group 1: Vizishot 22G
- Group 2: Vizishot Flexneedle 19G
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 open enrollment opportunities for this research study?
"The clinical trial is actively recruiting, as per the details on clinicaltrials.gov. The project was first posted on January 1st 2019 and recently edited February 15th 2023."
Answered by AI
What is the cap on the size of this medical experiment?
"Affirmative. Per the information provided on clinicaltrials.gov, this trial is still recruiting participants. The listing was posted to the website on January 1st 2019 and revised most recently on February 15th 2023. A total of 50 individuals are needed from a single research centre for enrollment purposes."
Answered by AI
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