Clinical trials

This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.

Laparoscopic radical prostatectomy (LRP) is the main treatment method for early prostate cancer, and postoperative urinary incontinence is one of the main complications after LRP. Urologists have applied various new operations in clinical practice to improve the urinary incontinence of patients after LRP surgery, but urinary incontinence is still the main problem affecting the quality of life of patients after surgery. In recent years, we have found that the new bladder neck urethral reconstruction method adopted by our department in LRP surgery can effectively improve the postoperative urinary incontinence of patients. In this study, a randomized controlled trial was intended to verify that the new bladder and neck urethral reconstruction technique could effectively improve early urinary control in patients after radical laparoscopic prostatectomy, and the patients were randomly divided into four groups by factorial design: posterior reconstruction group, posterior reconstruction +anterior suspension group, Sham group, and anterior suspension group to further verify the influencing factors of improved urinary control. The aim is to prove that the new operation can effectively reduce the urinary incontinence rate of patients after LRP, and analyze the mechanism of the new operation to improve the urinary incontinence of patients after LRP, and provide a new idea for the reconstruction of bladder neck and urethra during laparoscopic radical prostatectomy.

This study aims to evaluate the effect of 12 week low-intensity pulse ultrasound (LIPUS) intervention on the maturation of newly constructed autologous arteriovenous fistulas in uremic patients. This study is a prospective, blinded, randomized controlled trial. This trial is divided into two stages. The first stage is a concept validation trial, which is a single center, prospective, blinded, randomized controlled clinical study. Subjects who meet the screening criteria are randomly divided into an intervention group and a control group in a 1:1 ratio. All subjects underwent safety and efficacy evaluations at the 2nd, 4th, 8th, 12th, and 4th week after treatment. After completing a 4-week follow-up of the 20th study subject, an analysis was conducted with the preset goal of achieving a higher maturation rate of arteriovenous fistula in the intervention group compared to the control group at the follow-up point, and the safety of the study was evaluated. The second stage is a key trial, which is a multicenter, prospective, blinded, randomized controlled clinical study. The inclusion criteria, primary and secondary endpoints, and safety endpoints of the study subjects remain unchanged, and the safety and efficacy of the overall population are evaluated.

This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C).

This study is a prospective cohort clinical trial that aims to investigate the safety and efficacy of a combined chemoradiotherapy and immunotherapy treatment for early postoperative cervical cancer. Specifically, this study seeks to evaluate the ability of MRD-based screening to detect and monitor changes in MRD status at different stages of treatment, its potential for use in monitoring patient recurrence rates and in prognosis evaluation. In addition, this study will investigate the safety and effectiveness of chemoradiotherapy combined with immunotherapy as a postoperative adjuvant therapy for patients identified to be at risk of early cervical cancer based on MRD screening.