UrolithiasisNCT07471711
A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy
A study testing percutaneous nephrolithotomy in people with Urolithiasis and Percutaneous Nephrolithotomy (PCNL), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urolithiasis, Percutaneous Nephrolithotomy (PCNL)
- What is being tested?
- percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong / 广东, 510120
About this study
Official title: 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:
- Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL?
- 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:
- Undergo PCNL with "Aircraft Nephroscope"
- Follow-up the stone-free rate for 2 weeks after surgery
- Conditions
- Urolithiasis, Percutaneous Nephrolithotomy (PCNL)
- Being tested
- percutaneous nephrolithotomy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy | Experimental | Not described Receives: Procedure: percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jul 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongda Liu, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471711
- Sponsor's protocol ID
- GYFYY20220701
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy: Design Features and Initial Linical Exprience
- ClinicalTrials.gov ID
- NCT07471711
- Acronym / sponsor ID
- GYFYY20220701
- Conditions
- Urolithiasis, Percutaneous Nephrolithotomy (PCNL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL?
- 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:
- Undergo PCNL with "Aircraft Nephroscope"
- Follow-up the stone-free rate for 2 weeks after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy | Experimental | Procedure: percutaneous nephrolithotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous nephrolithotomyAfter 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. | Procedure or surgery | Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy |
Primary outcome
Stone-free rate
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous nephrolithotomy in people with Urolithiasis and Percutaneous Nephrolithotomy (PCNL), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.