XRAIconnect Image Guidance Software for ERCP Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for an ERCP at NYU Langone Health (NYULH);
First time ERCP for any indication; OR
ERCP (first-time or repeat) specifically for intrahepatic interventions, including placement of intrahepatic stent, access to intrahepatic stones, and access to intrahepatic strictures;
Aged 18 years or over;
Disqualifiers
Preprocedural or intraprocedural imaging of insufficient quality;
Pregnant or breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
XRAIconnect
DeviceMedical 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: ERCP CasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
Fluoroscopy time
Time frame
Approximately Week 8 (Day of Procedure)2
Total procedure time
Time frame
Approximately Week 8 (Day of Procedure)3
Number of cannulation attempts
Time frame
Approximately Week 8 (Day of Procedure)4
Number of wires used
Time frame
Approximately Week 8 (Day of Procedure)Sponsors and contacts
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Source ClinicalTrials.gov
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