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

NCT06914986 | Not Yet Recruiting DMC

• 1 other identifier: 24747-0-02
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urinary Calculi

Keywords

partial staghorn renal calculi

Outcome Measures

Primary Outcomes (1)

• stone free rate

  Patient will have CT scan 3 month after surgery

  3 month after surgery

Secondary Outcomes (1)

• complications

  3 month after surgery

Study Arms (2)

flexible and navigable suction ureteral access sheath combined with needle perc

EXPERIMENTAL

Procedure: Performed flexible and navigable suction ureteral access sheath combined with needle perc

PCNL group

OTHER

Procedure: PCNL

Interventions

Performed flexible and navigable suction ureteral access sheath combined with needle perc PROCEDURE

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

flexible and navigable suction ureteral access sheath combined with needle perc

PCNL PROCEDURE

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

PCNL group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

bo xiao, M.D.

CONTACT

86+13811403056; beidaxiaobo@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective Multicenter Randomized Controlled Trial

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 7, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE