Outcomes of Using FANS With FURS in TTT of Lower Calyceal Stones.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZagazig University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients ≥ 18 years old.
Patients with lower calyceal stones scheduled for FURS.
Disqualifiers
patients with active urinary tract infections.
Patients with renal and ureteric anomalies.
patients with coagulopathy
patients who are refusing to participate.
Trial design
Design model
Single group
Treatments tested in this trial
flexible and navigable suction sheath with flexible ureteroscopy
Deviceplacement 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.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: main arm .. single armExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
1 month after the procedure (preferred and most common for SFR assessment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov