FANS-Assisted Mini-PCNL for Complex Renal Stones (FANS-perc)

Guangzhou Medical University

Status: Enrolling

Conditions: Kidney Stones

Treatments: Procedure: FANS-assisted mini-percutaneous nephrolithotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07332286

ES-2025-252-02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Uncontrolled urinary tract infection at the time of surgery
• Known bleeding tendency or coagulation disorders
• Contraindication to general anesthesia
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

FANS-assisted mini-PCNL

Experimental group

Description:

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.

Treatment:

Procedure: FANS-assisted mini-percutaneous nephrolithotomy