Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) ProcedureNCT07841886
XRAIconnect Image Guidance Software for ERCP Procedures
A study testing XRAIconnect in people with Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure
- What is being tested?
- XRAIconnect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Preprocedural or intraprocedural imaging of insufficient quality;
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- XRAIconnect
- Keywords
- ERCP, endoscopic retrograde cholangiopancreatography, intrahepatic stones, intrahepatic stent, intrahepatic strcutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: XRAIconnect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean fiducial registration error
Mean fiducial registration error is a measure of goodness of fit of the registration; measured in mm.
Measured: 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.
Measured: Approximately Week 8 (Day of Procedure)
Secondary outcomes (6)
Fluoroscopy time
Measured: Approximately Week 8 (Day of Procedure)
Total procedure time
Measured: Approximately Week 8 (Day of Procedure)
Number of cannulation attempts
Measured: Approximately Week 8 (Day of Procedure)
Number of wires used
Measured: Approximately Week 8 (Day of Procedure)
Need for advanced cannulation techniques
Measured: Approximately Week 8 (Day of Procedure)
Post procedure complications within 24 hours
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) ProcedureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamas Gonda, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841886
- Sponsor's protocol ID
- 26-00478
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be specific to proprietary algorithm being studied in this trial and not relevant to outside researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XRAIconnect ERCP - A Single-center Feasibility Study of XRAIconnect Image Guidance Software for ERCP Procedures
- ClinicalTrials.gov ID
- NCT07841886
- Acronym / sponsor ID
- 26-00478
- Keywords
- ERCP, endoscopic retrograde cholangiopancreatography, intrahepatic stones, intrahepatic stent, intrahepatic strcutures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP Cases | Experimental | Device: XRAIconnectPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled for an ERCP at NYU Langone Health (NYULH);
- ERCP type:
- 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.
Key exclusion criteria (2 listed)
- Preprocedural or intraprocedural imaging of insufficient quality;
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XRAIconnectMedical 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. | Device | ERCP Cases |
Primary outcome
Mean fiducial registration error
Time frame: Approximately Week 8 (Day of Procedure)
Mean fiducial registration error is a measure of goodness of fit of the registration; measured in mm.
Mean multiplanar triangulation error
Time frame: Approximately Week 8 (Day of Procedure)
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Data will be specific to proprietary algorithm being studied in this trial and not relevant to outside researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamas Gonda, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XRAIconnect in people with Patients Scheduled for Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamas Gonda, MD (646-501-2465, Tamas.gonda@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean fiducial registration error (time frame: Approximately Week 8 (Day of Procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.