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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06914986
Enrollment
344
Registered
2025-04-07
Start date
2025-04-01
Completion date
2028-03-01
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Calculi

Keywords

partial staghorn renal calculi

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 the safety of drug ABC. The main questions it aims to answer are: * Does flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL * Does flexible and navigable suction ureteral access sheath combined with needle perc result in more complications compared with PCNL Researchers will compare flexible and navigable suction ureteral access sheath combined with needle perc result in similar stone free rate compared with PCNL to see if flexible and navigable suction ureteral access sheath combined with needle perc works to treat partial staghorn renal calculi. Participants will: * Performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL * Visit the clinic after surgery 1 month and 3 month for checkups and tests

Interventions

PROCEDUREPerformed flexible and navigable suction ureteral access sheath combined with needle perc

Patients are performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

PROCEDUREPCNL

Patients were performed flexible and navigable suction ureteral access sheath combined with needle perc or PCNL

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A Prospective Multicenter Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 18-80 years 2. CT scan indicates partial staghorn calculi 3. Able to complete the study in accordance with the protocol requirements 4. Informed about the study and has signed the informed consent form

Exclusion criteria

1. Severe renal insufficiency (GFR \< 30 ml/min/1.73 m²) 2. Significant calyceal hydronephrosis (calyceal width ≥ 2 cm) 3. Renal stone volume \> 33.5 cm³ 4. 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. 5. Congenital or structural renal abnormalities: spinal deformity, ankylosing spondylitis, horseshoe kidney, medullary sponge kidney, duplicated kidney, polycystic kidney, ectopic kidney, etc. 6. History of previous open renal stone surgery 7. Patients with uncontrolled urinary tract infections 8. Subjects deemed by the investigator to have other factors that make them unsuitable for participation in this trial

Design outcomes

Primary

MeasureTime frameDescription
stone free rate3 month after surgeryPatient will have CT scan 3 month after surgery

Secondary

MeasureTime frameDescription
complications3 month after surgeryPatients were recorded complications after surgery

Contacts

Primary Contactbo xiao, M.D.
beidaxiaobo@163.com86+13811403056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026