Validation of an AI-based Biliopancreatic EUS Navigation System for Real-time Quality Improvement: A Prospective, Single-center, Randomized Controlled Trial

NCT05457101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-06-22

No results posted yet for this study

Summary

Endoscopic ultrasonography (EUS) is a key procedure for diagnosing biliopancreatic diseases. However, the performance among EUS endoscopists varies greatly and leads to blind areas during operation, which impaired the health outcome of patients. We previously developed an artificial intelligence (AI) device that accurately identifies EUS standard stations and significantly reduces the difficulty of ultrasound image interpretation. In this study, we updated the device (named EUS-IREAD) and assessed its performance in improving the quality of EUS examination in a single-center randomized controlled trial.

Conditions

  • Endoscopic Ultrasonography
  • Pancreatic Disease
  • Bile Duct Diseases
  • Artificial Intelligence

Interventions

OTHER

AI-based biliopancreatic EUS navigation system

The endoscopists in the experimental group will be assisted by EndoAngel, which can in real-time prompt standard stations and anatomical structures during EUS. The system is an non-invasive AI system .

Sponsors & Collaborators

  • Renmin Hospital of Wuhan University

    lead OTHER

Principal Investigators

  • Honggang Yu, Doctor · Renmin Hospital of Wuhan University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-07-01
Completion
2023-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457101 on ClinicalTrials.gov