FANS-Assisted Mini-PCNL for Complex Renal Stones

NCT07332286 | Active Not Recruiting

• 1 other identifier: ES-2025-252-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Stones

Keywords

PCNL; FANS; kidney stone; mini-PCNL

Outcome Measures

Primary Outcomes (1)

• Immediate stone-free rate

  Absence of residual stones or fragments \>2 mm detected by non-contrast CT

  Postoperative day 0 to 3

Secondary Outcomes (6)

• Stone-free rate at 1 month

  Postoperative day 30 (±7 days)

• Operative time

  From skin puncture to completion of the procedure (intraoperative period)

• Postoperative pain score

  Postoperative day 1

• Postoperative complications

  Postoperative day 0 to 30

• Length of postoperative hospital stay

  Postoperative day 0 to postoperative day 14

Study Arms (1)

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.

Procedure: FANS-assisted mini-percutaneous nephrolithotomy

Interventions

FANS-assisted mini-percutaneous nephrolithotomy PROCEDURE

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

Also known as: Mini-PCNL using a flexible mini-nephroscope with suction access sheath

FANS-assisted mini-PCNL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: Vice chairman

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 12, 2026
• Study Start: December 19, 2025
• Primary Completion: April 12, 2026
• Study Completion: April 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)