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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosed with kidney stones, benign prostatic hyperplasia, or bladder cancer in line with the Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases (2022 Edition) and requiring hospitalization for surgery.

Disqualifiers

Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.

Trial design

Treatments tested in this trial

  • UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education
  • Physician-led Urological Diagnosis, Treatment & Preoperative Education

Treatment groups

1,080 Participants
are divided into 2 treatment groups

Locations

5
China
The First Affiliated Hospital of Guangxi Medical University530021, NanningGuangxi, China
Vietnam
Binh Duong General Hospital820000, Thu Dau MotBinh Duong Province, Vietnam
Viet Duc University Hospital HanoiHanoi, Vietnam
Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City Ho Chi Minh CityHo Chi Minh City (Municipality), Vietnam

Sponsors and collaborators

First Affiliated Hospital of Guangxi Medical University

Lead sponsor