NCT07076589

Brief Summary

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

June 13, 2025

Last Update Submit

March 8, 2026

Conditions

Ureter StonesStones, Kidney

Outcome Measures

Primary Outcomes (1)

  • • Stone-free rate (SFR).

    12 weeks postoperatively

Study Arms (2)

Using FANS

ACTIVE COMPARATOR

After the successful induction of anesthesia, the lithotomy position will be adopted. Ureteroscopy will be used with the aid of a safety guidewire to evaluate the condition of the ureter. The serial dilation of the ureter using ureteral dilators up to 14 Fr . The FANS will be then inserted into the ureter under the guidance of the safety guidewire. The FANS tip will be positioned in the renal pelvis or calyces near the location of the stone. The FANS will be connected to a vacuum device, and the negative pressure will be applied. The actual intraoperative negative pressure value will be adjusted by the urologist through a pressure adjustment vent as needed. The irrigation volume was set using peristaltic pumps. Lithotripsy will be conducted using the holmium: yttrium aluminum garnet laser applying the dusting technique of laser lithotripsy. During lithotripsy, the FANS will allow us to retrieve most of the fragmented stone particles by application of the suction pressure. All cases w

Procedure: FURS

Using traditional UAS

ACTIVE COMPARATOR

The method of anesthesia, patient positioning, ureteral dilation, and lithotripsy were the same as those used in the FANS group. For the traditional UAS group, the end of the UAS will be positioned underneath the ureteropelvic junction (UPJ). The irrigation volume is applied using peristaltic pumps. The dusting technique of laser lithotripsy will be applied to the stones. All cases will be stented using JJ stents with the suitable size.

Procedure: FURS

Interventions

FURSPROCEDURE

FURS using traditional UAS \& FANS

Using FANSUsing traditional UAS

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥14 years old in patients not known to have stone forming medical conditions.
  • Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching \& non-branching).
  • Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.
  • Patients with non - infected urine analysis.

You may not qualify if:

  • Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit).
  • Patients with medical conditions promoting stone formation (hyperparathyroidism - gout).
  • Patients with history of stones on the same side with previous open surgical intervention or PCNL .
  • Patients with e-GFR \< 60 ml / min.
  • Patients with uncontrolled urinary tract infection.
  • Patients with health or other factors that are absolute contraindications to RIRS.
  • Patients who are unable to understand or complete trial documentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Yehia Abdelaziz Mohammed, Professor of urology

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yosseif Ammar, MBBCH

CONTACT

201226912630yosefelhousseiny@gmail.com

Ahmed Yehia Abdelaziz Mohammed, Professor of urology

CONTACT

201229793766mailto:dr_ahmedyehia81@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 13, 2025

First Posted

July 22, 2025

Study Start

June 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 3, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

all collected IPD, all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After finishing the study and for 1 whole year

Locations

EG(1)