NCT06654271

Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging

Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging: the RELIANT 2 Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.

Detailed description

Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.

Conditions

• Peripheral Pulmonary Lesion
• Lung Nodule, Solitary

Interventions

Type	Name	Description
DEVICE	Robotic assisted bronchoscopy (RAB)	Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography
DEVICE	Electromagnetic navigation bronchoscopy (ENB)	Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-10-14
• Completion: 2026-10-14
• First posted: 2024-10-23
• Last updated: 2025-10-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study