Clinical Trial to Evaluate the Safety and Clinical Outcomes of the LuX-Valve Plus Transvenous Artificial Tricuspid Valve System in Patients with Severe or Worse Tricuspid Regurgitation
Study Name: Clinical Trial to Evaluate the Safety and Clinical Outcomes of the LuX-Valve Plus Transvenous Artificial Tricuspid Valve System in Patients with Severe or Worse Tricuspid Regurgitation
Site: Beijing Anzhen Hospital Affiliated to Capital Medical University
Sponsor: Jenscare Scientific (Netherlands) B.V.
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.
Real-World Clinical Outcomes Observation of Drug-Eluting Vertebral Artery Stent System for the Treatment of Atherosclerotic Stenosis: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Study
Study Name: Real-World Clinical Outcomes Observation of Drug-Eluting Vertebral Artery Stent System for the Treatment of Atherosclerotic Stenosis: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Study
Site: Nanfang Hospital, Southern Medical University
Sponsor: Nanfang Hospital, Southern Medical University, Alain Medical (Beijing) 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.
Preclinical Analytical Performance Evaluation of Hepatitis C Virus Antibody Test Kit (Colloidal Gold Method)
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.
Human PIK3CA Gene Mutation Detection Kit (Fluorescent PCR Method) Clinical Trial
Study Name: Human PIK3CA Gene Mutation Detection Kit (Fluorescent PCR Method) Clinical Trial
Site: Cancer Hospital Chinese Academy of Medical Sciences
Sponsor: QIAGEN Shanghai
Third-party Lab: RuiBiotech Beijing
HGRAC Approval Time: October 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.
Prospective, Randomized Controlled Clinical Study on Transthoracic and Bronchoscopic Ablation Treatment of Early-stage Peripheral Lung Cancer
Study Name: Prospective, Randomized Controlled Clinical Study on Transthoracic and Bronchoscopic Ablation Treatment of Early-stage Peripheral Lung Cancer
Site: Shanghai Chest Hospital
Sponsor: Broncus Medical, Hangzhou
HGRAC Approval Time: October 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.
A Feasibility Clinical Study to Evaluate the Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation
Study Name: A Feasibility Clinical Study to Evaluate the Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation
Site: Shandong Provincial Hospital Affiliated to Shandong First Medical University (Shandong Provincial Hospital)
Sponsor: Lixiao Medical, Shanghai
HGRAC Approval Time: October 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.
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: Zhongnan Hospital of Wuhan University
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
HGRAC Approval Time: October 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.
A Post-Market Study to Evaluate the Efficacy and Safety of the XEN45 Glaucoma Treatment System in Subjects with Open-Angle Glaucoma in China
Study Name: A Post-Market Study to Evaluate the Efficacy and Safety of the XEN45 Glaucoma Treatment System in Subjects with Open-Angle Glaucoma in China
Site: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor: Allergan
HGRAC Approval Time: October 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.
Evaluation of the Safety and Efficacy of High-Intensity Focused Ultrasound Treatment for Benign Prostatic Hyperplasia under General and Epidural Anesthesia - A Prospective, Multicenter, Randomized Controlled Clinical Trial
Study Name: Evaluation of the Safety and Efficacy of High-Intensity Focused Ultrasound Treatment for Benign Prostatic Hyperplasia under General and Epidural Anesthesia - A Prospective, Multicenter, Randomized Controlled Clinical Trial
Site: The First Affiliated Hospital of Navy Medical University of the Chinese People's Liberation Army
HGRAC Approval Time: October 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.
A Multicenter Randomized Controlled Clinical Trial Comparing Dedicated Magnetic Resonance Imaging with Surgical Staging for Peritoneal Metastases from Colorectal Cancer
Study Name: A Multicenter Randomized Controlled Clinical Trial Comparing Dedicated Magnetic Resonance Imaging with Surgical Staging for Peritoneal Metastases from Colorectal Cancer
Site: Fudan University Shanghai Cancer Center
Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
HGRAC Approval Time: October 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.