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Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones

Primary Purpose

Renal Stones

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single use flexible ureteroscopy (PUSEN-OLIMPUS)
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Stones focused on measuring Single use flexible ureteroscopy- renal stones

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Staghorn stones

Sites / Locations

  • Hossam abdelruhman kandeel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pt underwent single use flexible ureteroscopy

Arm Description

Patients with renal stones who will operated by single use flexible ureteroscopy

Outcomes

Primary Outcome Measures

Clearance of renal stones
the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones

Secondary Outcome Measures

Post operative complications after flexible ureteroscopy
Post operative complications as fever , haematuria are common after ureteroscopy

Full Information

First Posted
September 28, 2020
Last Updated
October 1, 2020
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04578795
Brief Title
Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones
Official Title
Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
Keywords
Single use flexible ureteroscopy- renal stones

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pt underwent single use flexible ureteroscopy
Arm Type
Experimental
Arm Description
Patients with renal stones who will operated by single use flexible ureteroscopy
Intervention Type
Device
Intervention Name(s)
Single use flexible ureteroscopy (PUSEN-OLIMPUS)
Intervention Description
single use flexible ureteroscopy
Primary Outcome Measure Information:
Title
Clearance of renal stones
Description
the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones
Time Frame
One month after operation
Secondary Outcome Measure Information:
Title
Post operative complications after flexible ureteroscopy
Description
Post operative complications as fever , haematuria are common after ureteroscopy
Time Frame
3 months after operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hossam abdelruhman kandeel
City
Shibīn Al Kawm
Country
Egypt

12. IPD Sharing Statement

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Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones

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