Outcomes of Using FANS With FURS in TTT of Lower Calyceal Stones.

NCT07238803 | Recruiting DMC

• 1 other identifier: 853
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones.

Conditions

Kidney Stone; Kidney Calculi

Keywords

Flexible Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi.

  This clinical study aims to evaluate the stone-free rate (SFR) following flexible ureteroscopy (FURS) in patients with renal or ureteral calculi. The primary outcome measure is the proportion of patients who achieve complete stone clearance, as determined by postoperative imaging (non-contrast CT or ultrasound) within a defined follow-up period.

  1 month after the procedure (preferred and most common for SFR assessment)

Study Arms (1)

main arm .. single arm

EXPERIMENTAL

Patients with lower calyceal stones

Device: flexible and navigable suction sheath with flexible ureteroscopy

Interventions

flexible and navigable suction sheath with flexible ureteroscopy DEVICE

placement of flexible and navigable suction sheath (FANS)which has an oblique side branch with pressure vent, that can be connected to negative pressure aspiration, and a flexible tip, allowing for efficient and effective treatment of urinary stones. * Flexible URS diameter will be at the least 2 Fr smaller than the sheath. * The main tube is closed by a rubber seal with a center aperture as the flexible ureteroscope pathway, The oblique tube with a pressure-regulating venting slit along the longitudinal axis acts as a suctioning channel connected to a vacuum device. * The inflow of irrigation is through the endoscope, the outflow of irrigation is between the scope and the sheath. * A vortex is created at the distal end of the sheath, the irrigation fluid, the stone fragments, dust, and blood, etc. in the vortex can be aspirated out. * The aspiration pressure can be adjusted by the pressure vent on the oblique side branch of the sheath.

Also known as: FANS ureteral access sheath

main arm .. single arm

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥ 18 years old.
• Patients with lower calyceal stones scheduled for FURS.

You may not qualify if:

• patients with active urinary tract infections.
• Patients with renal and ureteric anomalies.
• patients with coagulopathy
• patients who are refusing to participate.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, 44511, Egypt

RECRUITING

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 Officials

• Abdul Latif Mohammed Zayed, professor of urology

  Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Ahmed Lasheen, Resident

CONTACT

+201069524468; ma.ahmed24@fakmed.zu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Resident

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)