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NCT Number: NCT06914986

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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

PCNL

Procedure

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

Primary outcomes

  1. stone free rate

    Time frame: 3 month after surgery

    Patient will have CT scan 3 month after surgery

Secondary outcomes

  1. complications

    Time frame: 3 month after surgery

    Patients were recorded complications after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

bo xiao, M.D.

CONTACT

[email protected]

86+13811403056

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2025
Registry last updated
Apr 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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