Trials Sponsors Conditions Drugs Pricing

Conditions

Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure

Keywords

ERCPendoscopic retrograde cholangiopancreatographyintrahepatic stonesintrahepatic stentintrahepatic strcutures

Outcome Measures

Primary Outcomes (2)

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 Outcomes (6)

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)
+1 more secondary outcomes

Study Arms (1)

ERCP Cases

EXPERIMENTAL

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

Interventions

XRAIconnectDevice

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.

ERCP Cases

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

NYU Langone Health
Otherlead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Study Officials

Tamas Gonda, MD
NYU Langone Health
PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamas Gonda, MD

CONTACT

646-501-2465 Tamas.gonda@nyulangone.org

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DEVICE FEASIBILITY
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 25, 2026

Study Start

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

November 2027

Estimated

XRAIconnect Image Guidance Software for ERCP Procedures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

ERCP Cases

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

ERCP Cases

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations