Clinical Efficacy and Safety of Hip/knee Replacement Assisted by Joint Replacement Navigation and Positioning System for Different Prostheses
Study Name: Clinical efficacy and safety of hip/knee replacement assisted by joint replacement navigation and positioning system for different prostheses
Site: West China Hospital of Sichuan University, The Fourth Medical Center of the PLA General Hospital, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine，The Second Xiangya Hospital, Central South University, The Second Affiliated Hospital of Army Military Medical University，The First Affiliated Hospital of Sun Yat-sen University，Union Hospital Affiliated to Fujian Medical University，The Second Hospital of Lanzhou University，The Second Affiliated Hospital of Harbin Medical University，Shanghai Tongji Hospital，Huazhong University of Science and Technology Union Shenzhen Hospital，Jiangjin Hospital Affiliated to Chongqing University
Target Disease: Osteoarthritis
Study Type: Interventional study
Study Design: Non randomized control
Study Objective: The purpose of this clinical trial was to investigate the compatibility and suitability of the joint replacement navigation and positioning system (YUANHUA) produced by Bone Shengyuan Robot (Shenzhen) Co., LTD., when used in different rostheses, and compare the effectiveness and safety of traditional surgical methods.
Inclusion Criteria: TKA: (1) Age 18-80 years old, gender is not limited; (2) Patients diagnosed with knee osteoarthritis who did not respond to conservative treatment; (3) Patients who were assessed by the investigator to require unilateral first knee replacement surgery; (4) The subjects fully understand the benefits and risks of this experiment and are willing to participate and sign the informed consent. THA: (1) Over 18 years old, gender is not limited; (2) Patients should have indications for hip replacement surgery; (3) Patients voluntarily participate in clinical trials and are willing to sign an informed consent form.
Exclusion Criteria：TKA: (1) Patients with neuromuscular insufficiency (e.g., paralysis, myolysis) that will lead to postoperative dysfunction affecting lower limb function; (2) Patients with severe internal or surgical diseases or weak constitution who cannot tolerate surgery; (3) Charcot's arthritis; (4) There is an active infection in the body (systemic or local infectious lesions); (5) Serious osteoporosis, metabolic bone disease, radiation bone disease, and tumor around the knee joint; (6) Patients expected to have poor compliance; (7) Pregnant or lactating women, or patients who have family planning during the clinical study; (8) Other situations in which the investigator considers it inappropriate to participate in the study. THA: (1) Neuromuscular dysfunction, such as paralysis, myolysis, or abductor weakness which can lead to postoperative hip instability or gait abnormalities in patients; (2) Patients with a history of infection or suspected/confirmed infection in the hip joint or other parts of the body; (3) Known patient has a history of allergies to one or more implanted materials; (4) Patients with severe internal and surgical diseases or weak physical constitution who cannot tolerate surgery; (5) Patients with poor expected compliance; (6) Pregnant or lactating women, or patients who have family planning during the clinical study; (7) Other situations in which the investigator considers it inappropriate to participate in the study.
Group 1: Robot-assisted total knee arthroplasty (rTKA), patients undergoing TKA assisted by joint replacement navigation and positioning system, Sample size 350
Group 2: Traditional manual total knee arthroplasty (mTKA),Patients undergoing traditional manual total knee arthroplasty, Sample size 350
Group 3: Robot-assisted total hip arthroplasty (rTHA),Patients undergoing THA assisted by joint replacement navigation and positioning system, Sample size 350
Group 4: Traditional manual total hip arthroplasty (mTHA),Patients undergoing traditional manual total hip arthroplasty, Sample size 350
Primary Indicator: Hip-knee-ankle, HKA; Accuracy of acetabular cup implantation
Secondary Indicator: Accuracy of prosthesis implantation, KSS, WOMAC, Operation time, Anterior inclination and abduction angle degrees of acetabular cup implantation, The percentage of safe zones for accurate implantation of acetabular cups, Lower limb length accuracy, Harris hip score
Blinding: Blinding evaluators
EC Approval Time: 01 Feb, 2024
Development and Validation of Prognostic Models Based on Machine Learning for Postoperative Survival in Patients with Cervical Cancer
Study Name: Development and validation of prognostic models based on machine learning for postoperative survival in patients with cervical cancer
Site: West China Second University Hospital of Sichuan University
Target Disease：Cervical Cancer
Study Type: Prognosis study
Study Design: Retrospective study, Sequential
Study Objective: Models for predicting cervical cancer survival was developed and validated using an artificial intelligence machine learning algorithm combined with perioperative data containing anaesthesia related events.
Inclusion Criteria: 1. Patients who underwent radical surgery for cervical cancer in West China Second Hospital of Sichuan University from January 1, 2014 to January 1, 2020 2.ASA grade I-III; 3. The time from operation to death exceeds 1 month
Exclusion Criteria: Non-radical surgery and re-surgery after recurrence
Group: Case series, Sample size: 2000
Primary Indicator: Death
Secondary Indicator: Recurrence
Additional Indicator: AUROC; DCA; C-index; Briers score
EC Approval Time: 05 July, 2022
The Effectiveness of Natural Orifice Uterine Suspension for Advanced Uterine Prolapse: A National Multicenter Study
Study Name: The effectiveness of Natural Orifice Uterine Suspension for advanced uterine prolapse: A national multicenter study
Site: 13 sites, West China Hospital, Sichuan University; Meishan City People’s Hospital; The First Affiliated Hospital of Chengdu Medical; Shunde Hospital of Southern Medical University; Anhui Medical University Affiliated Maternity and Child Health Hospital; the Affiliated Hospital of Qingdao University; Affiliated Hospital of Inner Mongolia Medical University; The First Affiliated Hospital, Zhejiang University School of medicine; The first peoples' hospital of Neijiang; The Affiliated Hospital of Guizhou Medical University; Qinghai Provincial People's Hospital; The First People’s Hospital of Kunming; Yan'an Hospital Affiliated to Kunming Medical University
Target Disease: Pelvic organ prolapse
Study Type: Observational study
Study Design: Retrospective study, Cohort
Study Objective: To explore the effectiveness and safety of Natural Orifice Uterine Suspension for advanced uterine prolapse.
Inclusion Criteria: 1. patients with advanced uterine prolapse (POP-Q stage >II) who prefer surgical treatment; 2. age ≥65 years old; 3. patients with an atrophic uterus.
Exclusion Criteria: 1. patients with a history of total or partial hysterectomy; 2. patients with any gynaecological malignancy or pathology (e.g., fibroids, adenomyosis, abnormal uterine bleeding, and cervical dysplasia); 3. patients with total or partial trachelectomy; 4. patients with a history of pelvic radiotherapy; 5. patients with a history of lower abdominal or pelvic operation; 6. coagulopathy; 7. any contraindication to general anesthesia surgeries.
Group: Patients underwent the Natural Orifice Uterine Suspension (the Natural Orifice Uterine Suspension), Sample size: 150
Primary Indicator: objective cure; subjective cure
Secondary Indicator: pelvic organ prolapse quantitation score; Pelvic Floor Impact Questionnaire (PFIQ - 7); Pelvic Floor Distress Inventory (PFDI - 20)
Adverse events: complication
EC Approval Time: 07 November, 2023
A Computer-aid Breast Cancer Adjuvant Diagnostic and Prognostic Prediction System Based on Deep Learning-based Multi-omics Analysis
Study Name: A computer-aid breast cancer adjuvant diagnostic and prognostic prediction system based on deep learning-based multi-omics analysis
Site: Guangdong Provincial People's Hospital
Target Disease: Breast cancer
Study Type: Diagnostic test
Study Design: Sequential
Study Objective: Aiming at the major clinical problem of the difficulty of accurate diagnosis and treatment of breast cancer, this project aims to comprehensively penetrate intelligence into the diagnostic and treatment process of breast cancer. By using deep learning technology to quantify, analyse and integrate the characteristics of multi-omics data to provide intelligent auxiliary diagnostic and treatment suggestions, so as to achieve individualized and accurate diagnostic and treatment of breast cancer, and ultimately to improve the prognosis of the patients.
Inclusion Criteria: ① Contains complete clinical and pathological information; ② Undergo imaging examination prior to any treatment.
Exclusion Criteria: ① Previous history of breast cancer treatment (including: anti-hormonal therapy, targeted therapy, radiotherapy, etc.);② Incomplete or poor quality MRI image;③ History of puncture within 6 months prior to MRI; ④ Failure to complete a full course of neoadjuvant therapy.
Gold Standard or Reference Standard: Pathological result
Index test: A computer-aid multimodal intergrated evaluation system
Target condition: Patients with complete pathological information and pre-treatment imaging. They were divided into groups according to different studies, such as the benign breast lesion group and the malignant breast lesion group.
Sample size: 30000
Primary Indicator: Area under the curve of the receiver operating characteristic
Secondary Indicator: Sensitivity; Specificity
EC Approval Time: 04 March, 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: Fujian Medical University Union Hospital
Sponsor: Shanghai MicroPort CardioFlow Medtech
HGRAC Approval Time: December 2023
Exploratory Clinical Study of Absorbable Drug-Eluting Vertebral Artery Stent Treatment for Vertebral Artery Stenosis
Study Name: Exploratory Clinical Study of Absorbable Drug-Eluting Vertebral Artery Stent Treatment for Vertebral Artery Stenosis
Site: Beijing Tiantan Hospital, Capital Medical University
Sponsor: Biotyx Medical, Shenzhen China
HGRAC Approval Time: December 2023
Research and System Construction of Early Detection of Gene Methylation in Endometrial Cancer
Study Name: Research and System Construction of Early Detection of Gene Methylation in Endometrial Cancer
Site: People's Hospital of Liaocheng City
HGRAC Approval Time: December 2023
Research and System Construction of Early Detection of Gene Methylation in Bladder Cancer
Study Name: Research and System Construction of Early Detection of Gene Methylation in Bladder Cancer
Site: People's Hospital of Liaocheng City
Sponsor: BioChain (Beijing) Science & Technology
HGRAC Approval Time: December 2023
Research and System Construction of Early Detection of Gene Methylation in Ovarian Cancer
Study Name: Research and System Construction of Early Detection of Gene Methylation in Ovarian Cancer
Site: People's Hospital of Liaocheng City
HGRAC Approval Time: December 2023
Clinical Trial on the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Tumors and Primary Brain Malignant Tumors
Study Name: Clinical Trial on the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) for Recurrent Head and Neck Tumors and Primary Brain Malignant Tumors
Site: Xiamen Humanity Hospital
Sponsor: Neuboron Medical, Xiamen
Third-party Lab: Nanjing Clinical Tech Laboratories
HGRAC Approval Time: December 2023