The purpose of this research is to establish the usability, feasibility and utility of using XRAIconnect, a software medical device for operative image guidance for endoscopic retrograde cholangiopancreatography (ERCP) procedures. There will be prospective enrollment of up to 50 adult patients (18 years or older) undergoing elective ERCP procedures to evaluate the device clinically. Participants' pre-operative magnetic resonance cholangiopancreatography (MRCP) imaging data will be used to create digital, 3D reconstructions of the biliary and pancreatic ducts and surrounding organs/pathology. These 3D models will be aligned with live, intra-operative 2D X-ray (fluoroscopy) videos/images during ERCP in a process known as registration. This allows operators to view anatomical structures in 3D, with (stereoscopically) or without the use of an Augmented Reality HMD (Apple Vision Pro). To perform a registration to align 3D models to the intra-operative 2D images, natural anatomical landmarks that can be consistently identified on all images act as surrogate fiducial markers. The study aims to demonstrate that XRAIconnect can be used successfully during ERCP procedures, producing 3D models of sufficient accuracy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
50
Medical device software that generates three-dimensional (3D) geometric models from pre-operative imaging, and is capable of aligning them to live 2D fluoroscopic imaging during interventions, to provide enhanced navigational cues and a native 3D understanding of the spatial relationships between instrumentation and patient anatomy. In the context of ERCP, XRAIconnect uses data from pre-operative MRCP data to generate 3D models of the hepatobiliary system and surrounding structures which can be aligned with live, intra-operative 2D X-ray (fluoroscopy) videos/images during ERCP in a process known as registration.
NYU Langone Health
New York, New York, United States
Mean fiducial registration error
Mean fiducial registration error is a measure of goodness of fit of the registration; measured in mm.
Time frame: Approximately Week 8 (Day of Procedure)
Mean multiplanar triangulation error
Mean multiplanar triangulation error is the error due to small inconsistencies in registration across the imaging planes which may cause the resulting 3D rays cast not to intersect at a single, consistent point in space, leading to a slight mismatch between the 2D and 3D correspondences; measured in mm.
Time frame: Approximately Week 8 (Day of Procedure)
Fluoroscopy time
Time frame: Approximately Week 8 (Day of Procedure)
Total procedure time
Time frame: Approximately Week 8 (Day of Procedure)
Number of cannulation attempts
Time frame: Approximately Week 8 (Day of Procedure)
Number of wires used
Time frame: Approximately Week 8 (Day of Procedure)
Need for advanced cannulation techniques
Time frame: Approximately Week 8 (Day of Procedure)
Post procedure complications within 24 hours
Time frame: within 24 hours
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