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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 below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have general anesthesia.
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I have high levels of carbon dioxide in my blood.
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I have severe high blood pressure in the lungs.
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I am currently taking clopidogrel.
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My blood pressure and heart rate are not stable.
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I do not have severe bleeding disorders.
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I have been diagnosed with sarcoidosis before.
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I have an infection in the area between my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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
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

Media Library

Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT05374447 — N/A
Mediastinal Lymphadenopathy Research Study Groups: EBUS-TBNA, EBUS-TBNA + EBUS-IFB
Mediastinal Lymphadenopathy Clinical Trial 2023: Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy Highlights & Side Effects. Trial Name: NCT05374447 — N/A
Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374447 — N/A
~16 spots leftby Nov 2025