A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy

March 10, 2026 updated by: Yongda Liu, The First Affiliated Hospital of Guangzhou Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong / 广东
      • Guangzhou, Guangdong / 广东, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with histories of renal transplant or urinary diversion;
  2. patients with congenital abnormalities;
  3. Pregnant patients;
  4. Patients with uncorrected coagulopathy and
  5. Patients with active urinary tract infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy
Procedure: percutaneous nephrolithotomy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stone-free rate
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYFYY20220701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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