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Renal StonesNCT04578795

Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones

A study testing Single use flexible ureteroscopy (PUSEN-OLIMPUS) in people with Renal Stones, run by Menoufia University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones Read more about this study

Who is it for?
Any age
Conditions the study is for
Renal Stones
What is being tested?
Single use flexible ureteroscopy (PUSEN-OLIMPUS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
1 Sep 2020to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Staghorn stones

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Hossam abdelruhman kandeel

    Shibīn al Kawm

Other trials in Egypt

About this study

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

Read the 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.
Conditions
Renal Stones
Being tested
Single use flexible ureteroscopy (PUSEN-OLIMPUS)
Keywords
Single use flexible ureteroscopy- renal stones
Medical subject headings
Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single use flexible ureteroscopy (PUSEN-OLIMPUS)Device

    single use flexible ureteroscopy

Study groups in NCT04578795
Study groupRoleWhat they receive
Pt underwent single use flexible ureteroscopyExperimentalPatients with renal stones who will operated by single use flexible ureteroscopy
Receives: Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance of renal stones

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

    Measured: One month after operation

Secondary outcomes (1)
  1. Post operative complications after flexible ureteroscopy

    Post operative complications as fever , haematuria are common after ureteroscopy

    Measured: 3 months after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start1 Sep 2020
  3. Primary completion1 Apr 2021 (estimated)
  4. Study completion30 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04578795
Sponsor's protocol ID
9-2020urol
Status last verified
Oct 2020
First submitted
28 Sep 2020
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Single use flexible ureteroscopy (PUSEN-OLIMPUS) in people with Renal Stones, run by Menoufia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance of renal stones (time frame: One month after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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