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An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models

NCT07555756 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1080

Last updated 2026-04-29

No results posted yet for this study

Summary

This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience.

Before the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it.

In the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist.

Two senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed.

Subsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.

Conditions

  • Kidney Calculi
  • Prostatic Hyperplasia
  • Urinary Bladder Neoplasms

Interventions

OTHER

UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education

This urological intervention uses the independently developed UroMed AI Doctor, a urology-specialized large language model system distinct from generic medical AI tools. Trained \*\*exclusively\*\* on the latest international urology guidelines and high-quality literature, it has a built-in data cleaning system blocking non-standard knowledge sources, eliminating factual deviations and guideline misalignment common in general LLMs. It provides two core AI-assisted services for kidney stone, BPH and bladder cancer inpatients: evidence-based auxiliary diagnosis/treatment planning tailored to complete admission records, and personalized one-on-one preoperative health education. Uniquely equipped with ASEAN multilingual interaction and lightweight edge deployment for cross-border use, all AI outputs strictly adhere to urological clinical norms, ensuring professional accuracy and safety unavailable in non-specialized medical AI interventions.

OTHER

Physician-led Urological Diagnosis, Treatment & Preoperative Education

This intervention consists of standard, physician-led urological care without any artificial intelligence support. Qualified urologists independently diagnose and create personalized treatment plans for inpatients with kidney stones, BPH, or bladder cancer, following official clinical guidelines and consensus. One-on-one preoperative education, including disease information, treatment procedures, and postoperative care, is provided directly by attending physicians. This arm represents routine clinical practice, serving as a clear, active comparator to the AI-assisted intervention, ensuring a direct, valid comparison in effectiveness and safety between traditional care and AI-supported care.

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-04-30
Completion
2029-07-31

Countries

  • China
  • Vietnam

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 NCT07555756 on ClinicalTrials.gov