Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07238803

Outcomes of Using Flexible and Navigable Suction Sheath With Flexible Ureteroscopy in Treatment of Lower Calyceal Stones: A Prospective Study

Led by Zagazig University · Updated on 2025-11-20

33

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the outcomes of flexible ureteroscopy (fURS) combined with a flexible and navigable suction ureteral access sheath (FANS) for treating lower calyceal kidney stones. This study focuses on adults with stones less than 2 cm, aiming to improve stone-free rates and reduce complications compared to traditional methods. Recent guidelines suggest fURS as a first-line treatment for stones between 11 and 20 mm, and FANS may offer further improvements in surgical success and safety. The study uses a device called the flexible and navigable suction sheath, which has a pressure vent that connects to a vacuum for suction during the procedure. This sheath is designed with a flexible tip to enable more effective removal of stone fragments and reduce intrarenal pressure. The irrigation fluid flows through the ureteroscope and is aspirated out via the sheath's suction channel, potentially enhancing stone clearance. Participants will undergo fURS with the FANS sheath as the main treatment intervention. Participants will be monitored to assess the stone-free rate one month after the procedure, which is the primary outcome. The study includes safety assessments related to complications and the need for further interventions due to residual fragments. Researchers will track the success of the procedure through imaging and clinical evaluations during follow-up visits. The total duration includes the treatment and one-month post-procedure assessment to evaluate outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 65 18 years old
  • Patients with lower calyceal stones scheduled for flexible ureteroscopy (FURS)
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure day

Participants undergo placement of a flexible and navigable suction sheath with flexible ureteroscopy to treat lower calyceal stones.

1 procedure visit (in-person)

Follow-up

Duration - 1 month

Participants are monitored after the procedure to assess stone-free status and recovery.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Zagazig University Hospitals

Zagazig, Egypt, 44511

Actively Recruiting

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Research Team

M

Mahmoud Ahmed Lasheen, Resident

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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