Comparison Between Different Types of Flexible Ureteroscopes

Ain Shams University180 enrolled

Overview

The current study aims to compare the performance of three distinct single-use digital flexible ureteroscope types in terms of cost-effectiveness, postoperative complications, operating time, and stone-free rates (SFRs).

Retrograde intrarenal surgery (RIRS) is the preferred treatment modality for renal stones measuring less than 20 millimeters (mm). Several types of flexible ureteroscopes are currently available on the market from different manufacturers. However, there is a shortage of comparative studies evaluating the performance of different single-use flexible ureteroscopes. This study aims to compare the performance of three different single-use digital flexible ureteroscopes in terms of cost-effectiveness, postoperative complications, operative time, and stone-free rates (SFRs).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Renal Calculi Nephrolithiasis

Interventions

LithoVue™ (Boston Scientific Corporation)DEVICE

Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.

WiScope® (OTU Medical Inc. (Silicon Valley, USA))DEVICE

Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope single-use digital flexible ureteroscope.

Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)DEVICE

Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 to 60 years. * Presence of renal stones measuring less than 20 millimeters (mm). Exclusion Criteria: * Renal stones larger than 20 millimeters (mm). * Uncontrolled bleeding disorders or coagulopathies. * Active urinary tract infection. * Renal failure. * Uncontrolled diabetes mellitus, hypertension, or hepatic dysfunction. * Pregnancy. * Abnormal urinary tract anatomy or known ureteric stricture. * History of previous open ureteric surgery.

Locations (1)

Ain Shams University hospital

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Cost-effectiveness of single-use flexible ureteroscopes

Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS).

Time frame: 4 weeks postoperatively

Secondary Outcomes

Operative Time and Postoperative Complications

Incidence of postoperative complications within the postoperative period.

Time frame: up to 4 weeks postoperatively

Central Contacts

Hesham E Khayrallah, Resident

CONTACT

+201016704043 heshamkhayrallah111@gmail.com

Ashraf M Satour, Lecturer

CONTACT

+201050505463

Data from ClinicalTrials.gov

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