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

NCT ID: NCT07238803

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-02-01

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.

Detailed Description

With the continued advancements of technology and increasing experience gained by urologists in ureteroscopic skills, fURS has become a standard treatment for kidney stones lesser than 2 cm in diameter. In the previous the European guidelines and American Urologic Association guidelines for management of urolithiasis, fURS were recommended as a second-line treatment for stones less than 2 cm after ESWL, however in the recent revision of the guidelines, RIRS can be used as the first-line management option especially for stones measuring between 11 and 20 mm.

The ureteral access sheath (UAS), initially introduced by Hisao Takayasu in 1974 Despite continued advances in retrograde intrarenal surgery (RIRS), recent real-world data for 6669 patients in the FLEXOR registry revealed residual fragments in 21.7% of patients, of whom 51.5% required a second intervention.

The sepsis rate in the same study was just 1.3%. Hence, there is still much to improve in terms of technical expertise and technology for RIRS. Many aids have been introduced to streamline RIRS and improve procedural success. These include suction via a scope or ureteral access sheath (UAS), postintervention catheters, slimmer single-use scopes, and high-power lasers, these improvements have made RIRS a standard of care according to international guidelines.

It has been reported that vacuum aided or suction aspiration sheaths have strong potential to improve the stone-free status (SFS) rate and minimize infectious compilations associated with the negative effects of high intrarenal pressure and temperature, However, the true potential of the advances for RIRS has yet to be investigated. The ideal game-changing technological innovation for RIRS should improve all key outcomes of the procedure, including the rate of immediate single stage SFS, perioperative and postoperative complications, and the reintervention rate for residual fragments. One recent advance that has shown much promise is a flexible and navigable sheath (FANS) So, we will conduct a prospective study to assess whether FANS could be a potential game-changer for RIRS in adults with lower calyceal stones instead of traditional UAS especially regarding stone-free rates (SFR), complications and cost.

Conditions

Kidney Stone; Kidney Calculi

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

main arm .. single arm

Patients with lower calyceal stones

Group Type: EXPERIMENTAL

flexible and navigable suction sheath with flexible ureteroscopy

Intervention Type: 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.

Interventions

flexible and navigable suction sheath with flexible ureteroscopy

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.

Intervention Type: DEVICE

Other Intervention Names

FANS ureteral access sheath

Eligibility Criteria

Inclusion Criteria

1. Adult patients ≥ 18 years old.

2. Patients with lower calyceal stones scheduled for FURS.

Exclusion Criteria

1. patients with active urinary tract infections.

2. Patients with renal and ureteric anomalies.

3. patients with coagulopathy

4. patients who are refusing to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mahmoud Ahmed Elsayed Ahmed Lasheen

Urology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdul Latif Mohammed Zayed, professor of urology

Role: STUDY_DIRECTOR

Zagazig University

Locations

Zagazig University Hospitals

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud Ahmed Lasheen, Resident

Role: CONTACT

ma.ahmed24@fakmed.zu.edu.eg

+201069524468

Facility Contacts

safaa abdelmoez elnaggar, professor

Role: primary

safaa_elnaggar@hotmail.com

+20 122 371 9011

Other Identifiers

853

Identifier Type: -

Identifier Source: org_study_id