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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic Yield
Secondary outcome measures
Complications
Duration of Procedure
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
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Who is running the clinical trial?
George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,719 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still accepting participants?
"According to the details listed on clinicaltrials.gov, this medical trial is not currently accepting new patients. Initially posted on 1 January 2023 and last updated 11 October 2022, there are 45 other studies actively seeking participants at present."
Answered by AI
To what demographic is eligibility for this research restricted?
"This trial will be recruiting 55 individuals, aged 18 or over, that are suspected to have mediastinal illnesses. The necessary conditions for participation include radiologic proof of lymphadenopathy in the hilum and/or mediastinum region, a diagnosis of sarcoidosis from either an attending pulmonologist or radiologist is required."
Answered by AI
Does this investigation accept enrollees aged 55 and over?
"This trial has specified that individuals aged 18-99 are qualified to participate. For those under 18 and over 65, there are two studies and 44 studies respectively available."
Answered by AI
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