A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy

NCT07471711 | Completed

• 1 other identifier: GYFYY20220701
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL?
2. 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.
3. 3.Undergo PCNL with "Aircraft Nephroscope"
4. 4.Follow-up the stone-free rate for 2 weeks after surgery

Conditions

Urolithiasis; Percutaneous Nephrolithotomy (PCNL)

Outcome Measures

Primary Outcomes (1)

• Stone-free rate

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy

EXPERIMENTAL

Procedure: percutaneous nephrolithotomy

Interventions

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.

Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong / 广东, 510120, China

Location

MeSH Terms

Conditions

Urolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Urology Department in First Affiliated Hospital of Guangzhou Medical University

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 13, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)