CLINICAL DYNAMICS

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

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

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

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

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

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

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.

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.

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.

Study Name: Preclinical Analytical Performance Evaluation of Hepatitis C Virus Antibody Test Kit (Colloidal Gold Method)
Site: The Second People's Hospital of Tianjin
Sponsor: InTec Products Inc., Xiamen
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.