Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-19
2026-03-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FANS-assisted mini-PCNL
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.
FANS-assisted mini-percutaneous nephrolithotomy
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
Interventions
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FANS-assisted mini-percutaneous nephrolithotomy
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Known bleeding tendency or coagulation disorders
* Contraindication to general anesthesia
* Pregnancy or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Guohua Zeng
Vice chairman
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ES-2025-252-02
Identifier Type: OTHER
Identifier Source: secondary_id
ES-2025-252-02
Identifier Type: -
Identifier Source: org_study_id
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