Urolithiasis
Conditions
Interventions
Ultra-Fine Diameter Holmium Laser Treatment Group:Perform flexible ureteroscopic lithotripsy with an ultra-fine diameter holmium laser lithotripter
Sponsors
Sun Yat-sen Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years old inclusive, of any gender, and capable of tolerating surgery; 2. Patients with upper urinary tract stones confirmed by imaging examinations during the screening period, whose maximum cumulative stone diameter <= 25 mm, and who are scheduled to receive flexible ureteroscopic lithotripsy; 3. Patients who voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria shall be excluded from this trial: 1. Presence of any anatomical abnormality of the urinary system that renders intracavitary surgery unfeasible; 2. Suspected or confirmed prostate cancer or other urinary tract malignancies; 3. Bleeding diathesis, coagulation disorders (prothrombin time prolonged to 1.5 times the upper limit of normal), thrombocytopenia (PLT < 80×10?/L), aplastic anemia or other hematologic diseases associated with bleeding risks; 4. Concurrent active systemic infectious diseases; 5. Severe spinal or hip deformities precluding placement in the lithotomy position; 6. Alanine transaminase (ALT) or aspartate transaminase (AST) levels exceeding 1.5 times the upper limit of normal during the screening phase; 7. Contraindications to surgery including severe urinary tract infection or intolerance to anesthesia; 8. Known hypersensitivity to the materials of the investigational device; 9. Current or past history of psychiatric disorders; 10. Pregnant or lactating women, and females planning pregnancy within 3 months; 11. Subjects deemed inappropriate for enrollment in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone-free rate at 1 month postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial stone-free rate;Device performance evaluation;Vital signs;Surgical complication rate;Laboratory tests;Surgical parameters;Intraoperative pressure and temperature, intraoperative blood loss; | — |
Countries
China
Contacts
Public ContactXu Kewei
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed