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Procedure
Robotic vs Electromagnetic Bronchoscopy for Pulmonary Nodules (RELIANT 2 Trial)
Nashville, TN
N/A
Recruiting
Led By Rafael Paez, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age at time of bronchoscopy
Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion
Must not have
Patient declines to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of procedure, approximately 60 minutes
Awards & highlights
No Placebo-Only Group
Summary
"This trial is comparing two different methods of using technology to perform lung biopsies. They want to see which method is better at helping doctors find and diagnose lung lesions during the biopsy procedure."
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Who is the study for?
This trial is for individuals who need a biopsy of lung nodules or lesions. Participants should be suitable candidates for bronchoscopy, a procedure to look inside the lungs' airways.Check my eligibility
What is being tested?
The RELIANT 2 study is comparing two advanced bronchoscopy techniques: Robotic Assisted Bronchoscopy (RAB) with CT imaging and Electromagnetic Navigation Bronchoscopy (ENB) with digital imaging, to see which one better identifies lung issues.See study design
What are the potential side effects?
Potential side effects from both RAB and ENB may include discomfort in the chest, coughing, bleeding at the biopsy site, or infection. The procedures are generally well-tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
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I am scheduled for a special lung scan to check a spot.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I choose not to participate in the trial.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of procedure, approximately 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of procedure, approximately 60 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Secondary study objectives
Duration of bronchoscopy (in minutes)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Robotic assisted bronchoscopy (RAB)Active Control1 Intervention
Robotic assisted bronchoscopy with integrated cone beam computed tomography
Group II: Electromagnetic navigation bronchoscopy (ENB)Active Control1 Intervention
Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis
Find a Location
Closest Location:Vanderbilt University Medical Center· Nashville, TN· 620 miles
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
919 Previous Clinical Trials
938,306 Total Patients Enrolled
1 Trials studying Peripheral Pulmonary Lesions
445 Patients Enrolled for Peripheral Pulmonary Lesions
Rafael Paez, MDPrincipal InvestigatorVanderbilt University Medical Center