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Completed

NCT Number: NCT07471711

A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy

The goal of this clinical trial is to introduce a novel multifunctional miniature endoscopic system, namely "Aircraft Nephroscope", for percutaneous nephrolithotomy (PCNL) to treat the patients with urolithiasis. The main questions it aims to answer are:

1. Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL? 2. What types of nephrocope the "Aircraft Nephroscope" is and what function does it have? Researchers will observe the surgical outcome through the stone-free rate and compliction rates.

Participants will:

1. Undergo PCNL with "Aircraft Nephroscope" 2. Follow-up the stone-free rate for 2 weeks after surgery

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong / 广东, 510120, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Serum creatinine (≤200 μmol/l);
  • American Society of Anesthesiology score of 1-3;
  • Agree to undergo PCNL with "Aircraft Nephroscope", provide written informed consent and adhere to the requirements of the trial.

Exclusion criteria

  • Patients with histories of renal transplant or urinary diversion;
  • patients with congenital abnormalities;
  • Pregnant patients;
  • Patients with uncorrected coagulopathy and
  • Patients with active urinary tract infections.

Treatment and study plan

percutaneous nephrolithotomy

Procedure

After all the preparations of the procedure, the operator could select the appropriate nephroscope based on the stone burden. It was feasible and efficient to use the F17 nephroscope for the removal of large and soft calculi through ultrasonic lithotripsy. If the stones were hard and large, it would be advisable to select the F12 nephroscope for stone removal through pneumatic lithotripsy or by using a laser fiber, and the negative pressure suction function could enhance efficiency. To minimize the wound size, it was advisable to select the F8 nephroscope for small stones and utilize its suction-evacuation function to extract the stones. For complex kidney stones, including multiple stones or staghorn stones, surgeons can choose from combinations of the F8 nephroscope, F12 nephroscope, and F17 nephroscope to completely remove the stones.

Primary outcomes

  1. Stone-free rate

    Time frame: From enrollment to the end of treatment at 2 weeks

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy: Design Features and Initial Linical Exprience

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

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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