XRAIconnect Image Guidance Software for ERCP Procedures

Conditions

• Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XRAIconnect — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Sep 25, 2026

Start date

Nov 30, 2026

Status verified

Sep 2026

Primary completion

Nov 30, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: ERCP Cases
  Patients scheduled for an ERCP procedure will undergo pre-operative MRCP imaging scans (MRI scans) which will be reconstructed into digital, 3D models of the biliary and pancreatic ducts and surrounding organs/pathology. At the ERCP visit and using XRAIconnect software, NYULH ERCP operators will align these models with live, intra-operative 2D X-ray (fluoroscopy) videos/images (registration), allowing operators to view anatomical structures in 3D, with (stereoscopically) or without the use of an extended reality head-mounted display. The accuracy of XRAIconnect in terms of mean fiducial registration error and mean multiplanar triangulation error will be measured.

Primary Outcome Measure

Mean fiducial registration error [ Time Frame: Approximately Week 8 (Day of Procedure) ]

Central Contacts

• Tamas Gonda, MD
  646-501-2465
  [email protected]

Locations (1)

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