Kidney StonesFANS-MiniPercNCT07332286
FANS-Assisted Mini-PCNL for Complex Renal Stones
A study testing FANS-assisted mini-percutaneous nephrolithotomy in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- FANS-assisted mini-percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Patients with renal stones measuring 2 cm or larger in maximum diameter
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Planned to undergo mini-percutaneous nephrolithotomy
- Able and willing to provide written informed consent
Who cannot join
- Uncontrolled urinary tract infection at the time of surgery
- Known bleeding tendency or coagulation disorders
- Contraindication to general anesthesia
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
About this study
Official title: Mini-percutaneous Nephrolithotomy With a Flexible Mini-nephroscope and a Flexible and Navigable Suction Access Sheath for Complex Renal Stones: A Prospective Pilot Study
This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones.
Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life.
This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.
Read the detailed description
Conventional mini-PCNL may be limited by restricted access to anatomically challenging calyces and inefficient evacuation of stone fragments when flexible nephroscopy is required.
A novel technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) has been developed to enable flexible intrarenal navigation combined with active suction during antegrade lithotripsy.
This prospective pilot study will enroll 30 consecutive patients undergoing FANS-assisted mini-PCNL for complex renal stones. The study focuses on feasibility, safety, and preliminary clinical outcomes, including stone clearance and perioperative morbidity. The results will serve as preliminary data for future confirmatory or comparative clinical trials.
- Conditions
- Kidney Stones
- Being tested
- FANS-assisted mini-percutaneous nephrolithotomy
- Keywords
- PCNL, FANS, kidney stone, mini-PCNL
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FANS-assisted mini-percutaneous nephrolithotomyProcedure or surgery
Also called Mini-PCNL using a flexible mini-nephroscope with suction access sheath
The procedure consists of mini-percutaneous nephrolithotomy (mini-PCNL) performed with the assistance of a flexible mini-nephroscope and a flexible and navigable suction access sheath (FANS).
Following standard percutaneous renal access and initial stone fragmentation using a rigid nephroscope, a flexible mini-nephroscope is introduced through the percutaneous tract to access calyces that are difficult to reach with rigid instruments. Holmium:YAG laser lithotripsy is then performed under flexible endoscopic visualization.
The flexible and navigable suction access sheath allows simultaneous irrigation and adjustable negative-pressure suction, enabling continuous evacuation of stone fragments during lithotripsy. Suction strength can be regulated intraoperatively to maintain a clear endoscopic field and facilitate controlled fragment removal.
This procedure is applied to all participants in this prospective pilot study and aims to evaluate the feasibility and safety of flexible suction
| Study group | Role | What they receive |
|---|---|---|
| FANS-assisted mini-PCNL | Experimental | Mini-percutaneous nephrolithotomy performed using a flexible mini-nephroscope combined with a flexible and navigable suction access sheath to facilitate flexible access and active stone fragment evacuation. Receives: Procedure: FANS-assisted mini-percutaneous nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate stone-free rate
Absence of residual stones or fragments >2 mm detected by non-contrast CT
Measured: Postoperative day 0 to 3
Secondary outcomes (6)
Stone-free rate at 1 month
Absence of residual stones or fragments >2 mm detected by non-contrast CT
Measured: Postoperative day 30 (±7 days)
Operative time
Total duration of the surgical procedure measured from puncture to completion of the operation
Measured: From skin puncture to completion of the procedure (intraoperative period)
Postoperative pain score
Postoperative pain assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Postoperative day 1
Postoperative complications
Incidence and severity of postoperative complications classified according to the Clavien-Dindo grading system
Measured: Postoperative day 0 to 30
Length of postoperative hospital stay
Duration of hospital stay measured from completion of the procedure to hospital discharge
Measured: Postoperative day 0 to postoperative day 14
Quality of life score
Health-related quality of life assessed using the Wisconsin Stone Quality of Life (WISQOL) questionnaire, which consists of 28 items scored on a 5-point Likert scale. Total scores range from 0 to 140, with higher scores indicating better quality of life.
Measured: Baseline and postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start19 Dec 2025
- Primary completion12 Apr 2026
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332286
- Sponsor's protocol ID
- ES-2025-252-02
- Other IDs
- ES-2025-252-02
- Acronym
- FANS-MiniPerc
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this is a single-center prospective pilot study with a small sample size, and the data will be used primarily for exploratory and hypothesis-generating purposes.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-percutaneous Nephrolithotomy With a Flexible Mini-nephroscope and a Flexible and Navigable Suction Access Sheath for Complex Renal Stones: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07332286
- Acronym / sponsor ID
- FANS-MiniPerc / ES-2025-252-02
- Conditions
- Kidney Stones
- Keywords
- PCNL, FANS, kidney stone, mini-PCNL
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 Jan 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.
This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones.
Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life.
This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.
Detailed description
Conventional mini-PCNL may be limited by restricted access to anatomically challenging calyces and inefficient evacuation of stone fragments when flexible nephroscopy is required.
A novel technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) has been developed to enable flexible intrarenal navigation combined with active suction during antegrade lithotripsy.
This prospective pilot study will enroll 30 consecutive patients undergoing FANS-assisted mini-PCNL for complex renal stones. The study focuses on feasibility, safety, and preliminary clinical outcomes, including stone clearance and perioperative morbidity. The results will serve as preliminary data for future confirmatory or comparative clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FANS-assisted mini-PCNL | Experimental | Procedure: FANS-assisted mini-percutaneous nephrolithotomyMini-percutaneous nephrolithotomy performed using a flexible mini-nephroscope combined with a flexible and navigable suction access sheath to facilitate flexible access and active stone fragment evacuation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years
- Patients with renal stones measuring 2 cm or larger in maximum diameter
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Planned to undergo mini-percutaneous nephrolithotomy
- Able and willing to provide written informed consent
Key exclusion criteria (4 listed)
- Uncontrolled urinary tract infection at the time of surgery
- Known bleeding tendency or coagulation disorders
- Contraindication to general anesthesia
- Pregnancy or breastfeeding
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 |
|---|---|---|
| FANS-assisted mini-percutaneous nephrolithotomyAlso: Mini-PCNL using a flexible mini-nephroscope with suction access sheathThe procedure consists of mini-percutaneous nephrolithotomy (mini-PCNL) performed with the assistance of a flexible mini-nephroscope and a flexible and navigable suction access sheath (FANS). Following standard percutaneous renal access and initial stone fragmentation using a rigid nephroscope, a flexible mini-nephroscope is introduced through the percutaneous tract to access calyces that are difficult to reach with rigid instruments. Holmium:YAG laser lithotripsy is then performed under flexible endoscopic visualization. The flexible and navigable suction access sheath allows simultaneous irrigation and adjustable negative-pressure suction, enabling continuous evacuation of stone fragments during lithotripsy. Suction strength can be regulated intraoperatively to maintain a clear endoscopic field and facilitate controlled fragment removal. This procedure is applied to all participants in this prospective pilot study and aims to evaluate the feasibility and safety of flexible suction | Procedure or surgery | FANS-assisted mini-PCNL |
Primary outcome
Immediate stone-free rate
Time frame: Postoperative day 0 to 3
Absence of residual stones or fragments >2 mm detected by non-contrast CT
6 secondary outcomes
Stone-free rate at 1 month
Time frame: Postoperative day 30 (±7 days)
Operative time
Time frame: From skin puncture to completion of the procedure (intraoperative period)
Postoperative pain score
Time frame: Postoperative day 1
Postoperative complications
Time frame: Postoperative day 0 to 30
Length of postoperative hospital stay
Time frame: Postoperative day 0 to postoperative day 14
Quality of life score
Time frame: Baseline and postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as this is a single-center prospective pilot study with a small sample size, and the data will be used primarily for exploratory and hypothesis-generating purposes.
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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 FANS-assisted mini-percutaneous nephrolithotomy in people with Kidney Stones, 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Immediate stone-free rate (time frame: Postoperative day 0 to 3). 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 15 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.