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Completed
NCT07377461
Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.
Conditions: Kidney Stones, Nephrolithiasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Barzilai Medical Center
Location: Barzilai University Medical Center Ashkelon
Summary
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain.
Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently.
This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types.
The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Presence of single or multiple renal stones measuring 10 mm or greater
Eligible for retrograde intrarenal surgery under general anesthesia
Ability to provide written informed consent
Exclusion Criteria:
Pregnancy
Active urinary tract infection at the time of surgery
Known bleeding disorders
Solitary kidney
Anatomical abnormalities of the urinary tract that could affect ureteroscopic access
Source: ClinicalTrials.gov (NCT07377461). StuddyBuddy aggregates publicly available trial information.