XRAIconnect ERCP - A Single-center Feasibility Study of XRAIconnect Image Guidance Software for ERCP Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean fiducial registration error
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Preprocedural or intraprocedural imaging of insufficient quality;
- •Pregnant or breastfeeding.
研究组 & 干预措施
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.
干预措施: XRAIconnect (Device)
结局指标
主要结局
Mean fiducial registration error
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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))