Status:
NOT_YET_RECRUITING
A Prospective Multicenter Randomized Controlled Trial of Flexible And Navigable Suction Ureteral Access Sheath Combined With Needle Perc for the Treatment of Partial Staghorn Renal Calculi
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
Urinary Calculi
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. It will also learn about t...
Eligibility Criteria
Inclusion
- Aged 18-80 years
- CT scan indicates partial staghorn calculi
- Able to complete the study in accordance with the protocol requirements
- Informed about the study and has signed the informed consent form
Exclusion
- Severe renal insufficiency (GFR \< 30 ml/min/1.73 m²)
- Significant calyceal hydronephrosis (calyceal width ≥ 2 cm)
- Renal stone volume \> 33.5 cm³
- Renal stones or nephrocalcinosis caused by genetic diseases or definite metabolic disorders that have not been ruled out, such as renal tubular acidosis, primary hyperoxaluria, primary hyperparathyroidism, etc.
- Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc.
- History of previous open renal stone surgery
- Patients with uncontrolled urinary tract infections
- Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT06914986
Start Date
April 1 2025
End Date
March 1 2028
Last Update
April 7 2025
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