Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones

• ClinicalTrials.gov Identifier: NCT04578795
• Recruitment Status: Active, not recruiting
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Sponsor: Menoufia University
• Information provided by (Responsible Party): Hossam Kandeel, Menoufia University

Study Description

Brief Summary:

To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones

Condition or disease	Intervention/treatment	Phase
Renal Stones	Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS)	Not Applicable

Detailed Description:

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones .

• Percutaneous nephrolithotomy (PCNL) is currently the gold standard for management of large renal calculi.
• PCNL is associated, however, with a higher complication rate, degree of risk, and longer recovery period compared with ureteroscopy - ESWL was introduced in the 1980s and quickly became the gold standard for the treatment of kidney stones . In the 1990s, URS emerged with the advantages of direct visualization and extraction of kidney calculi .
• Currently, the American Urological Association guideline recommends ESWL or URS as equivalent first-line interventions for the treatment of kidney stones < 20 mm . - The guidelines of the European Association of Urology (EAU) additionally distinguish between lower pole and non-lower pole kidney stones. They recommend both treatments as equivalent options for kidney stones of 1020 mm, but favor URS for lower pole stones if adverse factors (such as anatomy and stone composition) argue against ESWL - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients .
• Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).
• we can distinguish two types of flexible URS: fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - In fiberoptic flexible URS, light and image are transmitted in analog format through fiberoptics bundles whereas illumination in digital scopes is made by fiberoptics or by a diode (DEL) and image capture charged by a digital sensor located at the tip of the endoscope: either charged coupled device (CCD) or complementary metal oxide semiconductor (CMOS ) - In both fiberoptic and digital flexible URS, most manufacturers have models with a 3.6 Fr working channel (for irrigation and use of accessory instruments) and at least one 270° active deflection of the tip. The most recent development in flexible URS was the introduction of single use digital flexible URS .
• On the other hand the traditional reusable scopes have a fixed purchase cost, there is additional cost related to scope processing and repairs . - The cost of single-use flexible URS is defined with the initial purchase price, whereas the procedural cost of reusable flexible URS is dependent on the initial and repair cost, maintenance and scope disinfection and on the number of procedures performed before it needs to be repaired. - There is also the cost of repair and the number of procedures with a refurbished scope until it has to be replaced.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: April 1, 2021
• Estimated Study Completion Date: July 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pt underwent single use flexible ureteroscopy; Patients with renal stones who will operated by single use flexible ureteroscopy	Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS); single use flexible ureteroscopy

Outcome Measures

Primary Outcome Measures :

1. Clearance of renal stones [ Time Frame: One month after operation ]
   the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones

Secondary Outcome Measures :

1. Post operative complications after flexible ureteroscopy [ Time Frame: 3 months after operation ]
   Post operative complications as fever , haematuria are common after ureteroscopy

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- All cases indicated for flexible in our department (stone kidney up to 2 cm - failed ESWL, difficult PCNL

Exclusion Criteria:

• Staghorn stones

Contacts and Locations

Locations

Egypt

Hossam abdelruhman kandeel

Shibīn Al Kawm, Egypt

Sponsors and Collaborators

Menoufia University

More Information

• Responsible Party: Hossam Kandeel, Urology resident _ menoufia Faculty of Medicine, Menoufia University
• ClinicalTrials.gov Identifier: NCT04578795
• Other Study ID Numbers: 9-2020urol
• First Posted: October 8, 2020
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hossam Kandeel, Menoufia University:

Single use flexible ureteroscopy- renal stones

Additional relevant MeSH terms:

Kidney Calculi; Nephrolithiasis; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Urolithiasis; Urinary Calculi