Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.

NCT07377461 | Completed

• 1 other identifier: 0069-24-BRZ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stones; Nephrolithiasis

Keywords

Retrograde Intrarenal Surgery; Ureteral Access Sheath; Suction Ureteral Access Sheath; Flexible Tip Ureteral Access Sheath; RIRS; Operative Time; Endourology

Outcome Measures

Primary Outcomes (1)

• Operative Time

  Operative time was defined as the duration from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure.

  During the surgical procedure

Secondary Outcomes (4)

• Intraoperative and Postoperative Complications

  Perioperative period (Day of surgery through postoperative Day 30).

• Stone-Free Rate

  Two weeks after surgery

• Length of Hospital Stay

  From end of surgery until hospital discharge (typically 1-3 days).

• Ureteral Wall Injury

  During the surgical procedure

Study Arms (2)

Flexible and Navigable Suction Ureteral Access Sheath (FANS)

EXPERIMENTAL

Participants underwent retrograde intrarenal surgery using a flexible and navigable ureteral access sheath with integrated suction capability.

Device: Flexible and Navigable Suction Ureteral Access Sheath (FANS)

Conventional Ureteral Access Sheath

ACTIVE COMPARATOR

Participants underwent retrograde intrarenal surgery using a standard, non-suction ureteral access sheath.

Device: Conventional Ureteral Access Sheath

Interventions

Conventional Ureteral Access Sheath DEVICE

Use of a standard ureteral access sheath without suction during retrograde intrarenal surgery.

Conventional Ureteral Access Sheath

Flexible and Navigable Suction Ureteral Access Sheath (FANS) DEVICE

Use of a flexible distal-tip ureteral access sheath with integrated suction during retrograde intrarenal surgery to facilitate access, irrigation control, and fragment evacuation.

Flexible and Navigable Suction Ureteral Access Sheath (FANS)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai University Medical Center

Ashkelon, 7830604, Israel

Location

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to one of two parallel intervention arms.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 30, 2026
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)