Comparing robotic and electromagnetic bronchoscopy for lung lesion biopsies
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging: the RELIANT 2 Trial
This study is testing whether robotic bronchoscopy or electromagnetic bronchoscopy is better at helping doctors get accurate biopsies of lung nodules in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT06654271 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of robotic assisted bronchoscopy using integrated cone beam computed tomography against electromagnetic navigation bronchoscopy with digital tomosynthesis for diagnosing peripheral pulmonary lesions. It is a pragmatic randomized controlled trial where patients scheduled for bronchoscopy will be assigned to one of the two techniques based on cluster randomization. The goal is to determine which method provides a higher diagnostic yield during the biopsy of lung nodules. The study will involve real-time imaging to enhance the accuracy of the procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for navigational bronchoscopy to evaluate a pulmonary lesion.
Not a fit: Patients who decline to participate or are enrolled in another trial requiring a specific navigational platform may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for patients with pulmonary lesions, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of robotic versus electromagnetic bronchoscopy with integrated imaging is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age at time of bronchoscopy * Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion Exclusion Criteria: * Patient declines to participate * Patients enrolled in another trial which requires the use of one specific navigational platform
Where this trial is running
Chicago, Illinois and 2 other locations
- Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Rafael Paez, MD — Vanderbilt University Medical Center
- Study coordinator: Rafael Paez, MD
- Email: rafael.paez@vumc.org
- Phone: (615) 322-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.