CompletedNot applicableNCT02146131

Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )

The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs. This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.

Checked against the public recordLast updated Sep 25, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations5
SponsorMedical University of South Carolina
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Medical University of South Carolina
Interventions being studied
Device: Standard FB with fluoroscopy; Device: R-EBUS with ultrathin bronchoscope
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up \>75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR 2. Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (\>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up \>75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy. 3. Are at least 22 years old, 4. Lack Bleeding disorders, and 5. Are able to provide informed consent Exclusion Criteria: 1. Patients with a pure ground-glass opacity identified on chest CT 2. Patients with endobronchial involvement seen on chest CT. 3. Patients who refuse to participate, 4. Are less than 22 years of age, 5. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and 6. Are unable to provide informed consent 7. Pregnant

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Medstar Washington Hospital CenterWashington D.C., District of Columbia
  • University of FloridaGainesville, Florida
  • Johns Hopkins UniversityBaltimore, Maryland
  • Washington University Saint LouisSt Louis, Missouri
  • Medical University of South CarolinaCharleston, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2018. Always confirm current availability with the study team.

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