Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654271
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging the RELIANT 2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIANT 2
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None