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Intranodal Forceps Biopsy for Sarcoidosis Diagnosis
N/A
Recruiting
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Be older than 18 years old
Must not have
Inability to undergo general anesthesia
Acute Hypercarbic Respiratory Failure (pCO2 >55mmHg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two methods for diagnosing sarcoidosis, endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and intranodal forceps biopsy (EBUS-IFB).
Who is the study for?
This trial is for adults with suspected sarcoidosis, indicated by a specialist's report and radiologic signs of lymph node swelling in the chest. It excludes those with severe respiratory failure, pulmonary hypertension, inability to undergo anesthesia, bleeding disorders, known sarcoidosis, clopidogrel use, unstable blood pressure or heart conditions.
What is being tested?
The study compares two biopsy methods to diagnose sarcoidosis: traditional needle aspiration (EBUS-TBNA) versus intranodal forceps biopsy (EBUS-IFB), focusing on which method more effectively confirms the diagnosis.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, risk of infection or bleeding due to tissue sampling and general anesthesia-related complications such as nausea or breathing difficulties post-procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have general anesthesia.
Select...
I have high levels of carbon dioxide in my blood.
Select...
I have severe high blood pressure in the lungs.
Select...
I am currently taking clopidogrel.
Select...
My blood pressure and heart rate are not stable.
Select...
I do not have severe bleeding disorders.
Select...
I have been diagnosed with sarcoidosis before.
Select...
I have an infection in the area between my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnostic Yield
Secondary study objectives
Complications
Duration of Procedure
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: EBUS-TBNA + EBUS-IFBExperimental Treatment1 Intervention
These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
Group II: EBUS-TBNAActive Control1 Intervention
These will be the patient who undergo EBUS-TBNA only without EBUS-IFB
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
252 Previous Clinical Trials
461,095 Total Patients Enrolled
Mardi Gomberg, MDStudy DirectorThe George Washington University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I cannot have general anesthesia.There are signs of swollen lymph nodes in the chest area on your X-rays or scans.My blood pressure and heart rate are not stable.I have high levels of carbon dioxide in my blood.I have severe high blood pressure in the lungs.I am currently taking clopidogrel.I do not have severe bleeding disorders.I have been diagnosed with sarcoidosis before.My lung doctor suspects I might have sarcoidosis.I have an infection in the area between my lungs.The doctor who gives you medicine to sleep during surgery thinks that you might have more problems with the medicine than other people.
Research Study Groups:
This trial has the following groups:- Group 1: EBUS-TBNA
- Group 2: EBUS-TBNA + EBUS-IFB
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.
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