Ureteral Stricture

The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.

The goal of this observational study is to investigate the systemic pathogenesis and identify potential diagnostic biomarkers in patients with ureteral stricture and healthy volunteers. The main questions it aims to answer are: What are the systemic differences in the gut microbiome, urine microbiome, and metabolomic profiles (fecal, urinary, and serum) between patients with ureteral stricture and healthy controls? What are the correlations between these microbial/metabolic alterations and clinical phenotypes, such as stricture severity, inflammatory levels, and renal function? Researchers will compare the biological panoramic profiles of patients with ureteral stricture to those of healthy controls to see if specific "microbiome-metabolite-disease" regulatory networks drive the development of the condition. Participants will: Provide stool samples for gut microbiome (16S/Metagenomics) and metabolomic analysis. Provide urine samples for urine microbiome and metabolomic analysis. Provide blood (serum) samples for systemic metabolomic profiling. Undergo clinical assessments, including medical history collection, imaging (e.g., CT/IVP), and laboratory tests (e.g., renal function, inflammatory markers) to evaluate disease severity.

The purpose of this clinical study is to evaluate the safety and efficacy of the Sten® Laparoendoscopic Surgical System C1000 for benign ureteral reconstruction surgery. This is a single-arm, open-label, prospective, non-randomized cohort study. Eligibility criteria for recruitment to this study included how to include labeling: (1) patients aged ≥18 years and ≤80 years, male and female; (2) patients who need to undergo upper urinary tract repair surgery; (3) patients who are suitable for ureteral reconstruction surgery as confirmed by the investigator; (4) subjects voluntarily participating in the clinical trial and agreeing to, or their guardian agreeing to, and signing an informed consent form; (5) willingness to cooperate with and complete the trial follow-up and related examinations. The research subjects of this project were recruited openly, and the patients were enrolled after being informed of the study-related information, risks and benefits by the project participants and then screened to meet the enrollment criteria. A total of 50 patients will be enrolled. The study objectives and endpoints include the following: primary endpoints: (1) the rate of surgical non-referral (2) the success rate of surgical treatment; secondary endpoints: (1) the loading time (2) the operating time of the surgeon (3) the estimated intraoperative blood loss (4) the postoperative patient's pain scores (5) the evaluation of the physiological load of the surgeon (6) the evaluation of the mental load of the surgeon (7) the rate of intraoperative transfusion (8) the duration of the hospital stay after the operation (9) the evaluation of physician satisfaction (9) the evaluation of physician's satisfaction). (9) Physician satisfaction rating (10) Overall postoperative complication rate (11) Adverse events and serious adverse events (12) Device defects (13) Postoperative readmission rate (14) Reoperation rate (15) Mortality rate. The expected overall duration is 9 months, with an expected enrollment time of 6 months and a subject follow-up time of approximately 3 months.

Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.