XRAIconnect Image Guidance Software for ERCP Procedures

XRAIconnect ERCP - A Single-center Feasibility Study of XRAIconnect Image Guidance Software for ERCP Procedures

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 Overview

• Status: Not yet recruiting
• Conditions: Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
• Intervention / Treatment: Device: XRAIconnect

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamas Gonda, MD; Phone Number: 646-501-2465; Email: Tamas.gonda@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled for an ERCP at NYU Langone Health (NYULH);

• ERCP type:

  • 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;

• Able to provide written consent to participate in the study (taken either in person during pre-ERCP hospital visit or by email via SendSafe);

• Have pre-operative MRCP imaging data available to transfer to Medical iSight Corporation with sufficient time available for data processing using the medical device (XRAIconnect software) prior to use during the ERCP.

Exclusion Criteria:

• Preprocedural or intraprocedural imaging of insufficient quality;
• Pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: XRAIconnect; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean fiducial registration error	Mean fiducial registration error is a measure of goodness of fit of the registration; measured in mm.	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.	Approximately Week 8 (Day of Procedure)

Secondary Outcome Measures

Outcome Measure	Time Frame
Fluoroscopy time	Approximately Week 8 (Day of Procedure)
Total procedure time	Approximately Week 8 (Day of Procedure)
Number of cannulation attempts	Approximately Week 8 (Day of Procedure)
Number of wires used	Approximately Week 8 (Day of Procedure)
Need for advanced cannulation techniques	Approximately Week 8 (Day of Procedure)
Post procedure complications within 24 hours	within 24 hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tamas Gonda, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): September 25, 2026
• Last Update Submitted That Met QC Criteria: September 21, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ERCP; endoscopic retrograde cholangiopancreatography; intrahepatic stones; intrahepatic stent; intrahepatic strcutures
• Other Study ID Numbers: 26-00478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data will be specific to proprietary algorithm being studied in this trial and not relevant to outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No