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  • 11 03 2024

Development of AI-based Digital Diagnostic and Treatment Equipment and Systems - Research and Development of Personalized Intelligent Diagnosis and Treatment System for Pulmonary Subsolid Nodules Based on Growth Laws and Multi-omics.

Study Name: Development of AI-based Digital Diagnostic and Treatment Equipment and Systems - Research and Development of Personalized Intelligent Diagnosis and Treatment System for Pulmonary Subsolid Nodules Based on Growth Laws and Multi-omics.
Site: Zhejiang Provincial Hospital of Chinese Medicine and the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Dongfang Hospital)
HGRAC Approval Time: December 2023

  • 11 03 2024

Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System


Study Name: Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System
Site: Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital (Sun Yat-sen Cardiovascular Hospital), Shenzhen, China
Sponsor: Shanghai MicroPort CardioFlow Medtech 
HGRAC Approval Time: December 2023


  • 11 03 2024

Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System

Study Name: Prospective, Single-Center, Exploratory Study Evaluating the Feasibility and Safety of Transcatheter Mitral Valve Replacement System
Site: The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
Sponsor: Shanghai MicroPort CardioFlow Medtech
HGRAC Approval Time: December 2023

  • 11 03 2024

Protocol for Establishing Reference Value Range of Protein C (PC) Activity Detection Reagent Kit (Chromogenic Substrate Method)

Study Name: Protocol for Establishing Reference Value Range of Protein C (PC) Activity Detection Reagent Kit (Chromogenic Substrate Method)
Site: Huaxin Hospital, Beijing (First Affiliated Hospital of Tsinghua University)
Sponsor: Shenzhen Mindray Biomedical Electronics Co., Ltd.
HGRAC Approval Time: December 2023

  • 11 03 2024

Protocol For Establishing CD3/CD16+56/CD45/CD19 Detection Reagent (Flow Cytometry-FITC/PE/PerCP/APC) Reference Range

Study Name: Protocol For Establishing CD3/CD16+56/CD45/CD19 Detection Reagent (Flow Cytometry-FITC/PE/PerCP/APC) Reference Range
Site: Huaxin Hospital, Beijing (First Affiliated Hospital of Tsinghua University)
Sponsor: Shenzhen Mindray Biomedical Electronics Co., Ltd.
HGRAC Approval Time: December 2023

  • 11 03 2024

Protocol For Establishing Lupus Anticoagulant (LA) Detection Reagent Kit (Coagulation Method) Reference Range

Study Name: Protocol For Establishing Lupus Anticoagulant (LA) Detection Reagent Kit (Coagulation Method) Reference Range 
Site: Huaxin Hospital, Beijing (First Affiliated Hospital of Tsinghua University)
Sponsor: Shenzhen Mindray Biomedical Electronics Co., Ltd.
HGRAC Approval Time: December 2023


  • 08 03 2024

Follow-up Study of the VitaFlow Transcatheter Aortic Valve System Registration Study

Study Name: Follow-up Study of the VitaFlow Transcatheter Aortic Valve System Registration Study
Site: Zhongshan Hospital Affiliated to Fudan University
Sponsor: Shanghai MicroPort Heart Access Medical Technology Co., Ltd.
Third-party Lab: Yingke MedTech Ltd., Beijing
HGRAC Approval Time: December 2023
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

  • 08 03 2024

Clinical Study on the Treatment of Urinary Tract Stones with the U200 Extracorporeal Shock Wave Lithotripsy Machine

Study Name: Clinical Study on the Treatment of Urinary Tract Stones with the U200 Extracorporeal Shock Wave Lithotripsy Machine
Site: Hospital of Traditional Chinese Medicine of Zhongshan City 
Sponsor: Shenzhen Huikang Precision Instruments Co., Ltd.
HGRAC Approval Time: December 2023
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

  • 08 03 2024

Evaluation of Prognostic Impact of Lesion-Specific Hemodynamic Index and Disease Characteristics in Patients with Coronary Artery Disease using Blood Flow Reserve Score (PRIME-FFR)

Study Name: Evaluation of Prognostic Impact of Lesion-Specific Hemodynamic Index and Disease Characteristics in Patients with Coronary Artery Disease using Blood Flow Reserve Score (PRIME-FFR)
Site: Yan'an Hospital (Cadre Convalescent Hospital) in Kunming City
Sponsor: Yan'an Hospital (Cadre Convalescent Hospital) in Kunming City
HGRAC Approval Time: December 2023
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.

  • 07 03 2024

A Prospective, Single-Center, Exploratory Study to Evaluate the Feasibility and Safety of the Transcatheter Mitral Valve Replacement System

Study Name: A Prospective, Single-Center, Exploratory Study to Evaluate the Feasibility and Safety of the Transcatheter Mitral Valve Replacement System
Site: Henan Provincial Chest Hospital
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
HGRAC Approval Time: November 2023
Note: HGRAC Approval or Filing (Human Genetic Resource Administration of China) is an important step before the first enrollment of subjects for clinical trials in China sponsored by foreign companies.