ureteral stricture
Conditions
Interventions
Experimental group (Feasibility Study):Drug-coated urethral balloon catheter produced by Lepu Medical Technology(Beijing)Co.,Ltd.
Control group (Confirmatory Trial):Urethral balloon catheter produced by Lepu Medical Technology(Beijing)Co.,Ltd.
Experimental group (Confirmatory Trial) :Drug-coated urethral balloon catheter produced by Lepu Medical Technology(Beijing)Co.,Ltd.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years,regardless of gender; 2. Ureteral stricture was confirmed by imaging , the length of ureteral stricture = 2 cm, and at most one stricture site of each ureter; 3. Hydronephrosis was confirmed by imaging; 4. Patients who understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo clinical follow-up according to the research requirements.
Exclusion criteria
Exclusion criteria: 1. Ureteral stricture caused by radiotherapy, ureteral tuberculosis, endometriosis, benign or malignant tumors of the ureter, and organ compression caused by other malignant tumors in the abdominal cavity that are not suitable for balloon dilation treatment; 2. Patients with indwelling ureteral stents or those who have undergone ureteral stenosis dilation or internal incision within the past 3 months; 3. Combined lower urinary tract obstruction or bladder dysfunction; 4. Patients with upper urinary tract non natural anatomical structures such as intestinal replacement ureter or ureter intestinal anastomosis; 5. Patients with concurrent urinary system tumors; 6. Patients with severe renal insufficiency, with blood creatinine>221 umol/L or undergoing dialysis; 7. Patients with affected side renal function 8.0%); 10. Patients with urolithiasis that affect balloon dilation treatment or uncontrollable urinary tract infections; 11. Patients with a history of allergies to paclitaxel, contrast agents, or anesthetics; 12. Patients with coagulation dysfunction; 13. Women during menstruation, pregnancy, or lactation, or patients with a planned pregnancy; 14. Patients who are participating in clinical trials of other drugs or medical devices and have not achieved their primary endpoint; 15. The researchers believe that patients who cannot participate in this clinical trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Device-Related Adverse Events (Feasibility Study);Operation success rate (Feasibility Study, Confirmatory Trial); | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate (Feasibility Study, Confirmatory Trial);Pain relief (Feasibility Study, Confirmatory Trial);Improvement of quality of life (Feasibility Study, Confirmatory Trial);Serum creatin (Feasibility Study, Confirmatory Trial);Glomerular filtration rate (Feasibility Study, Confirmatory Trial);Affected side renal function (Feasibility Study, Confirmatory Trial) ;Affected side pyelic separation (Feasibility Study, Confirmatory Trial);Incidence of Device-Related Adverse Events (Feasibility Study, Confirmatory Trial);Clavien-Dindo Classification of Postoperative Complications(Feasibility Study, Confirmatory Trial);Instrument defect rate(Feasibility Study, Confirmatory Trial) ;Adverse Events (Feasibility Study, Confirmatory Trial);Operation success rate (Feasibility Study); | — |
Countries
China
Contacts
Public ContactLi Xuesong
Peking University First Hospital
Outcome results
None listed